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Gloves knowledge

 Glossary

 

No
Subject
Explanation
1.
510(K)
Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k). Medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected
2.
ADA
Dentists and consumers have long recognized the American Dental Association (ADA) Seal of Acceptance as an important symbol of a dental product's safety and effectiveness. Participating manufacturers commit significant resources to test and market products in the Seal program.
3.
Air Pump Test
Air pump test serves to check for holes and visual defects in gloves.
4.
Allergic Reaction
Allergy is defined as abnormal or exaggerated and sometimes harmful reactions to external substances called allergens.
5.
Ambidextrous
Gloves that can be used either on the right hand or left hand without compromising the usage.
6.
AQL
Acceptable Quality Level
AQL 1.0,1.5, 2.5: Suitable for medical gloves
AQL 4.0: Suitable for non medical gloves
7.
ASTM (American Society for testing and Material)
ASTM International is one of the largest voluntary standards development organizations in the world-a trusted source for technical standards for materials, products, systems, and services. Known for their high technical quality and market relevancy, ASTM International standards have an important role in the information infrastructure that guides design, manufacturing and trade in the global economy.
8.
ASTM D3577
D3577-01ae2 Standard Specification for Rubber Surgical Gloves.
9.
ASTM D3578
D3578-01ae2 Standard Specification for Rubber Examination Gloves.
10.
ASTM D5250
D5250-00e4 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application.
11.
ASTM Standards
It is the standards and methods used to test the gloves for medical grade that conforms to the American Standard Testing Method (ASTM).
12.
Barcode
Identification code consisting of a series of vertical bars of variable width that are scanned by a laser; printed on consumer product packages to identify the item for a computer that provides the price and registers inventory information.
13.
Barrier Protection
To provide a layer of protection from factors that is to be avoided.
14.
Beaded Cuff
Beaded cuff is to prevent gloves from rolling down.
15.
Bio-compability
A test to determine if a product causes irritation and sensitization to humans or animals.
16.
Carton
Case that house the inner / dispenser boxes.
17.
Caution Statement
Caution statement is applicable for all powdered gloves US shipment, where a statement of protein content must be added into the inner box. This will inform the user on the existence of protein.
18.
CE
CE Mark, or CE marking as it is officially named, is an obligatory product mark for the European market, which indicates compliance 'certification' according to the requirements formulated in the approximately 22 European 'CE Marking Directives' and subsequent European standards. Therefore, the CE mark is important for manufacturers and importers placing products in the European market.
19.
CGSB
ASTM International is one of the largest voluntary standards development organizations in the world-a trusted source for technical standards for materials, products, systems, and services. Known for their high technical quality and market relevancy, ASTM International standards have an important role in the information infrastructure that guides design, manufacturing and trade in the global economy.
20.
Chemical residue
Chemical compounds are used during the manufacturing of gloves, which may remain in varying amounts. Water leaching helps reduce these residues.
21.
Chlorination
A process of producing powder free gloves by treating these gloves with chlorine. It also removes the first layer of protein to an acceptable level.
22.
Cleanroom Gloves
Cleanroom gloves area gloves used in a highly close-up environment where bacteria are at the minimal rate. All cleanroom gloves have to be sterilized.
23.
Coagulant dipping
Formers are woulds dipped into the coagulant tank to extract the protein from the previous glove dipping. This dipping are done once for every production cycle.
24.
Compounding
It is the process where chemicals are added to produce a good mixture of latex for the production of gloves.
25.
Cornstarch
The cornstarch is used for all powdered gloves. Cornstarch act as the owder?for easy donning purposes.
26.
Cuff
Cuff is the opening of gloves.
27.
Dimension
Dimension is the measures of all angle for carton, inners and gloves.
28.
Disposable
Disposable reflect single use only. All disposable gloves are advised to be used once only.
29.
Donning
Donning means the act of putting on the gloves on the hand.
30.
Double Chlorination
Gloves are chlorinated twice in the double chlorination process.
31.
Double Wall
Double wall applies to the thickness of the carton boxes.
32.
Drying
A process of drying the gloves from wet to ready made gloves.
33.
Elongation at Break
Elongation test is one our testing method to measure the strength of our gloves. Results are taken once the gloves break when during the stretching (elongation) test.
34.
EN
European Norm certification indicates compliances with the European Quality System Regulation (QSR)
35.
Examination Extractable Proteins
Most allergy cases are caused by protein found in latex gloves. Therefore, it is tested that water can extract a certain class of protein. ASTM D5712 standard for testing extractable proteins using a modified Lowry Method for common determination.
36.
FDA
Food and Drug Administration. It is the United State抯 authority body that regulated approval for import of goods into the States.
37.
FDA Import Alert 80-04
It is the surveillance and detention without physical examination of surgeon抯 and/or patient examination gloves. Automatic Detention program developed by the FDA to monitor and control glove products manufacturers by firms who repeatedly import non-compliance products.
38.
Former, hand
Former is the mold used to produce gloves.
39.
Gamma Irradiation/Sterilization
Sterilization is a process of using gamma ray radiation to extract bacteria in the gloves.
40.
Glove Count
Glove count is the number of gloves found in an inner/ carton
41.
GMP
Good Manufacturing Practice, a guidelines proposed by FDA to ensure quality in production of biomedical products.
42.
Grip
To secure and maintain a tight hold on.
43.
HACCP
Hazard Analysis and Critical Control Point (HACCP) ?based food system has been introduced by FDA to monitor and control food supply into USA market by ensuring it is safe from hazardous.
44.
Hat Yai
It is the fourth (4th) largest city in Thailand. Top Glove factory is located 10 km on the way to Hat Yai from Malaysia-Thailand Border.
45.
Household Gloves
Household gloves are gloves used in industrial use.
46.
Hypoallergenic
Having a decreased tendency to provoke an allergic reaction
47.
Industrial Gloves
Non-medical grade gloves.
48.
Inner
Inner is the box used for keeping the gloves in place. Every carton has 10 inners are inserted into a carton.
49.
Irritation
Irritation is caused by allergy of either latex or powder from the gloves. Symptoms of irritation are rash and itchiness.
50.
ISO 9001
ISO 13485
ISO is a network of the national standards institutes of 146 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. Therefore, ISO acts as a bridging organization in which a consensus can be reached on solutions that meet both the requirements of business and the broader needs of society, such as the needs of stakeholder groups like consumers and users.
51.
Latex
Commonly, it is referring to a milky (usually whitish) fluid obtained from over 1,000 species of trees and plants. It is the most important raw material used for the production of latex gloves, natural rubber latex, which is derived from the Hevea Brasiliensis tree species found mainly in South East Asia though they originated from Brazil.
52.
Latex Dipping
It is one of the stations in the production process of latex gloves manufacturing whereby the tank is filled with compounded latex. Once the formers go through this tank, it will pick up and form a latex layer on it.
53.
Latex Free (non-latex)
Contain no natural rubber latex (Kindly refer to synthetic rubber)
54.
Leaching
A washing process commonly used during the glove manufacturing process using hot water to remove the protein, residue chemicals and particles from the glove.
55.
Length
Glove length is measured from the tip of the middle finger to the outside edge of the cuff. The normal standard for examination glove length is about 240mm , while for surgical gloves is 280mm and 300mm for household, cleanroom and 12?high risk gloves.
56.
Long-Length 12" High Risk Gloves
It is actually glove made from natural rubber latex but it is different from the standard examination gloves because its length is 12?(300mm) instead of 9?(240mm). Usually this glove is used in industrial industry. The extra length provides additional protection from unwanted and dangerous substance.
57.
Lot Number
It is an indication of when and from which factory the specific gloves have been produced. Top Glove 揑n-House Lot Number?goes by 12 or 13 digits for record and tracing purpose. However, private lot number is still acceptable upon request.
58.
Major Defects
Defects that may cause the glove to fail in its performance and lower the barrier protection. (i.e. pinhole)
59.
Medical Device Licence (MDL)
Companies exporting or wishing to export to Canada medical devices of class II and above are required to have a Medical Device Licence issued by Health Canada. Effective January 1, 2003 all Canadian and Foreign manufacturers applying for a new Medical Device Licence, or applying for renewal of an existing Medical Device Licence are required to submit an ISO 13485 or ISO 13488 Certificate of Registration issued by a CMDCAS Recognized Registrar together with their application.
60.
Minor Defects
Defects that unlikely to reduce the usability and performance of the gloves such as discoloration or small dirt.
61.
Modulus
It is actually a measurement for the resistance of stretch, whereby the lower the modulus means the gloves is much more flexible and elastic to move thus less fatigue on the hands.
62.
Moisture Content
Amount of water exist in the glove, which need to be control at the minimum to prevent discoloration of glove..
63.
Natural Rubber Latex
Kindly refer to Latex and Rubber.
64.
NF Mark
It is a voluntary certification mark in France. NF means "Normes Fran ises", French Standards.
65.
Nitrile
One of the synthetic gloves that is produced from the synthetic latex of Acrylonitrile Butadiene Copolymer type, which is resistance to oil and exhibiting rubber-like characteristics.
66.
Non-Medical
Gloves can be categorized into medical and non-medical industry whereby the non-medical is referred to the usage in industrial industry, which is non-related to medical field some examples include; food industry, electronic and etc. The word industrial?is used interchangeable with on-medical.
67.
Non-Sterile
Examination and non-medical gloves are normally nonsterile. This means that the gloves are not subjected to gamma irradiation that kill micro-organisms.
68.
Particulate
Minute separate particle, as of a granular substance or powder.
69.
Permeation

Process which a chemical can pass through a protective film without going through pinholes, pores, or other visible openings. It抯 data can be presented in two values:-
i) Breakthrough Time
?Times observed from the start of the test to first detection of the chemical on the other side of the sample.
?These times represent how long a glove can be expected to provide effective permeation resistance when totally immersed in the test chemical.

ii) Rate ?The highest flow recorded for the permeating chemicals through the glove samples during a six-hour test.
?These qualitative ratings are comparisons of permeation rates to each other.

70.
Pinhole
The most important aspect in assessing the standard of the gloves. Pinholes are tiny holes in gloves that are detected using air pump or water tight test.
71.
Polyethylene Glove (PE Glove)
Disposable polyethylene or PE gloves are made with materials approved by USDA, provide protection from organic vapors, dusts and mists thus making them a smart choice for any food service application. All of the gloves are powder free. Our polyethylene gloves are printed with an embossed finish on both sides to improve grip and is ambidextrous to fit either hand.
72.
Polymers
A process of producing powder free gloves by treating these gloves with chlorine. It also removes the first layer of protein to an acceptable level.
73.
Polyvinyl Chloride (PVC)
It is a polyvinyl resin used extensively in the manufacturing of medical devices such as gloves and it also used as a rubber substitute. Kindly refer to Vinyl Gloves
74.
Powdered
Due to the natural sticky characteristic of latex, powder is used as the means to prevent the gloves from sticking together and ease of donning. Donning powder on gloves is composed of cornstarch (USP absorbable dusting powder).
75.
Powder-Free
The technology to prevent stickiness of gloves by avoiding powder usage completely by going through chlorination or polymer coating process.
76.
Pre-Leaching
Kindly refer to Leaching.
77.
Protein content
All natural rubber latex products contain protein. For latex gloves, it is the measurement of total protein regardless of allergenic content. The ASTM D5712 standard is using the test method in the Modified Lowry assay for analysis of aqueous Extractable Protein Natural Rubber.
78.
Quality Assurance
All planned and systematic actions required to provide adequate confidence that the glove satisfy the necessary needs. Top Glove抯 gloves are consistently tested to ensure that it meet the Acceptable Quality Level (AQL) before it is exported.
79.
Residual Powder
It measured the excess powder beyond what is required.Currently the test measured total powder extractable in water.
80.
Rubber
An elastic substance produces from latex of Hevea Braziliensis (rubber tree).
81.
Shelf Life
The expiry date for the usage of the gloves. For Powdered and Powder Free Gloves show a shelf life of 5-years.
82.
Single Wall
Referring to the flute of the carton box. Single wall mean that the layer in-between for the carton is only one layer.
83.
SIRIM
The Standards and Industrial Research Institute of Malaysia (SIRIM) is a national multi-disciplinary research and development agency under the Ministry of Science, Technology and the Environment. Established in 1975 under the SIRIM (incorporation) Act 157, SIRIM was set-up to assist companies solve technical problems through the use of technology and help their business growth.
84.
Size
Glove size is determined by measuring the circumference of the hand around the palm area with a tape measure. The usual size standard for examination gloves are of XS ?XL while surgical gloves are of 6.5 ?8.5.
85.
Slurry Dipping
Slurry dipping tank consisting of solution of corn-starch to prevent gloves sticking inside.
86.
SMG
The Standard Malaysian Glove (SMG) is produced by glove manufacturers under certification by the Malaysian Rubber Board (MRB), with a quality assurance in line with the technical specifications of the American Society for Testing and Materials (ASTM) and the U.S. Food and Drug Administration (FDA), In addition, SMG-certified manufacturers must have a Quality Management System equivalent to ISO 9001:2000.
87.
Smooth
Even surface of the gloves by using smooth surface former.
88.
Songkhla
The Thai province of Songkhla is located in the southern Peninsula Malaysia to the south and the gulf of Thailand to the east. Top Glove抯 Factory 7 is located in city of Hatyai, which is located in this Songkhla province.
89.
Sterile
Sterile gloves are those gloves that have gone through sterilization process to assure that it is without any living organisms.
90.
Sterilization
Using Gamma Irradiation to eliminate all microbial life, including highly resistant bacterial spores.
91.
Stripping
The manual or automated process of removing gloves from the formers, where they are turned inside out. Top Glove憇 latex examination gloves are stripped by fully automated stripping machine.
92.
Surgical Gloves
This glove is meant for the usage in surgery room for the surgery operation. Need to be sterilized and it is hand-specific to prevent hand fatigue during surgery process.
93.
Synthetic Rubber
Alternative to natural rubber. It is produced by chemical synthesis. Type of synthetic gloves produced by Top Glove is nitrile and vinyl gloves.
94.
Tactile Sensitivity
This is an important aspect in selecting glove because the tactile sensitivity of the user while wearing the glove can ensure good performance. Therefore, the thinner the glove is, the better the tactile sensitivity it provide.
95.
Tensile Strength
It is a measurement of the stretch required to break the glove material. Gloves with good vulcanized process tend to have higher tensile strength.
96.
Textured
Textured surface on the glove, which is caused by the uneven surface of the formers. Textured gloves will provide better grip.
97.
TGA
The Therapeutic Goods Administration (TGA) is a unit of the Australian Government Department of Health and Ageing. The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances including medical device such as gloves.
98.
Thickness
Measurement of glove surface depth protecting skin from exposure to elements. It is measured on a single wall using a micrometer over several parts of the glove, typically at the cuff, the mid-palm and the finger sections.
99.
Tumbling
Tumbling process removes excessive powder on the glove.
100.
Vinyl Glove
Polyvinyl chloride (PVC) glove is a type of synthetic gloves, which is used as an alternative to natural rubber latex examination glove.

 Glove Selection Guide

GLOVE PERFORMANCE INDICATOR

Your Best Choice Of Glove
The following comparisons serve as a guide for users to choose the right glove material for each application.
It allows users to choose the optimal glove depending on the purpose and application.

Properties
Natural Latex
Nitrile
Vinly
PE
Barrier Properties against Viral Transmission
Tear Resistance
Puncture Resistance
Tensile Strength and Elasticity
Protein Content
Present
Not Present
Not Present
Not Present
Comfort, finger dexterity to reduce hand fatigue
Tactile sensitivity for better feel
Resistant to oils and solvents
Resistant against chemicals
Food Contact Safety
Biodegradable and environmental friendly
Price

Indicator: Fair Good Excellent

 Type of Gloves

Latex Examination Gloves
Made from natural rubber latex (NRL), it offers its users the best barrier protection in areas of potential risk associated with blood-borne pathogens and other substances or biohazards. The physical properties of the material provide excellent flexibility and uncompromised protection with high degree of sensitivity. It provides excellent comfort and feel. Latex outperforms other glove materials in terms of elasticity and tensile strength. Latex examination gloves are generally affordable and economical in terms of pricing.

Nitrile Examination Gloves
Nitrile gloves are made from Acrylonitrile-butadiene, a synthetic polymer. It is made from synthetic rubber which is non-latex and protein free, hence suitable for users who are sensitive to natural rubber proteins. Soft formulation or low modulus nitrile gloves provides excellent feel, fit, comfort and flexibility to users and reduces hand fatigue. It has good resistance to oil, grease and wide range of toxic chemicals and solvents. Nitrile gloves posses high abrasion and puncture resistance properties. Its elasticity is good but less superior as compared to natural rubber. It is generally more costly than natural rubber gloves.

Vinyl Examination Gloves
Made from Poly Vinyl Chloride (PVC). It is ideal for users who are sensitive to natural rubber latex protein allergy. Vinyl gloves have good resistance to oil, ozone, grease, acid and bases. Vinyl provides a relaxed and comfortable fit that feels like a second body skin. Soft vinyl formulation offers greater comfort, fit and better flexibility. It has anti-static properties suitable for cleanroom and critical environment applications. Vinyl gloves are generally very affordable and economical.

Medical Gloves
The highest quality of Medical-Grade Exam Gloves is to act as a reliable, protective barrier which prevents the transmission of organisms and blood-borne pathogens to its users. Exam gloves are not necessary in sterile form, it can be in non-sterile to protect your hands from exposure. It is widely used in hospitals (outside operating theatre) and other industrial and home applications.

iGlove offers the highest quality of Medical-Grade Exam Gloves available in Latex, Nitrile and Vinyl for both powdered and powder-free gloves.

Surgical Gloves
Sterile Surgical Gloves are at the top of the range of quality protective gloves and are typically used by surgeons and operating room staffs. Top Glove offers a full range of premium quality Latex Powdered and Powder-Free Sterile Surgical Gloves.

Disposable Gloves
Disposable Gloves are generally used in the following applications: Food handling, salons/spas, electronic assemblies, laboratorial work, packing process, automotive, janitorial, general pharmaceutical and home use/DIY. These gloves are not recommended for medical use, especially to prevent transmission of organisms, blood-borne pathogens and protection against various chemicals.

Cleanroom Gloves
Made from natural rubber latex (NRL), it offers its users the best barrier protection in areas of potential risk associated with blood-borne pathogens and other substances or biohazards. The physical properties of the material provide excellent flexibility and uncompromised protection with high degree of sensitivity. It provides excellent comfort and feel. Latex outperforms other glove materials in terms of elasticity and tensile strength. Latex examination gloves are generally affordable and economical in terms of pricing.

Household Gloves
Household Gloves are used for industrial, domestic cleaning, food processing and handling purposes. It provides excellent abrasion, cut and tear resistance with excellent grip and dexterity. It also protects against alkalis but not against petroleum and other oil based solvents.

General Purpose Gloves
Made from natural rubber latex (NRL), it offers its users the best barrier protection in areas of potential risk associated with blood-borne pathogens and other substances or biohazards. The physical properties of the material provide excellent flexibility and uncompromised protection with high degree of sensitivity. It provides excellent comfort and feel. Latex outperforms other glove materials in terms of elasticity and tensile strength. Latex examination gloves are generally affordable and economical in terms of pricing.

Polyethylene Gloves
Disposable polyethylene or PE gloves are made with materials approved by USDA, provide protection from organic vapors, dusts and mists thus making them a smart choice for any food service application. All of the gloves are powder free. Our polyethylene gloves are printed with an embossed finish on both sides to improve grip and is ambidextrous to fit either hand.

Selecting the Right Glove

Safety & Protection
This should be the main priority to protect users from any blood form or other substances which they come into contact with

Comfort & Fit
Gloves are for protection and at the same time provide its users the comfort when performing their tasks. In terms of performance, latex glove are regarded as providing excellent elasticity and fitting.

Concerns on Allergy
The above issue has been a concern to all users of Latex products. However, if you choose to use latex gloves it is recommended to use powder free latex gloves or powdered gloves with reduced protein content. Perfect alternatives would be synthetic Vinyl and Nitrile gloves. Soft formulations of vinyl and nitrile gloves provide the degree of comfort and sensitivity close to Latex gloves but are more expensive in terms of pricing.

Quality versus Cost
Question of cost over quality has been the main issue when deciding on using the different type of gloves. The vital factor to consider when deciding on using the glove is to get the highest acceptable quality standards at the best or optimum value you can obtain. Latex and vinyl gloves are generally very affordable whilst nitrile and other synthetic gloves are usually more costly.


 
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