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 Quality Assurance

1. What quality controls do you have in your factories ?

We emphasize on stringent quality control procedures in line with MS ISO 9001, QSR regulation system, and in compliance with ASTM D3578 and EN455 standards. We strongly stress on Total Quality Management and the Quality Control tests are conducted from the point we receive our raw materials straight through the production processes and the finished products points. Compulsory pre-shipment inspections are carried out before the delivery of each order.

2. What is distinct about Top Glove's manufacturing practices ?

With our state-of-art high technology and efficient automatic glove manufacturing machines, we continue to obtain the most productive manufacturing yield and to remain as one of the most cost-effective and highest quality producer in the industry.

Our factories are also strategically located less than 10 km from the largest seaport in Malaysia i.e. Port Klang. The port, with its modern facilities and direct calls arrangement with all major ports around the world is capable of ensuring timely deliveries without delays.

3. Do you have the FDA 510Ks for export to the USA ?

Yes, we have the FDA 510Ks for numbers export to the USA for our whole range of products as follow :-

-Latex Powder Examination Gloves
-Latex Powder Green & Blue Examination Gloves
-Latex Powder Green Mint Examination Gloves
-Latex Powder-free Examination Gloves
-Latex Powder-free Polymer-bonded Latex Examination Gloves
-Latex Powder Long-length High Risk Gloves
-Latex Powder-free Long-length High Risk Gloves
-Latex Powder Surgical Gloves
-Latex Powder-free Surgical Gloves
-Nitrile Powder Examination Gloves
-Nitrile Powder-free Examination Gloves
-Nitrile Blue Powder Examination Gloves
-Nitrile Blue Powder-free Examination Gloves
-Vinyl Powder Examination Gloves
-Vinyl Powder-free Examination Gloves
-Polyethylene Gloves
-Polyethylene Apron
-Stretchy Vinyl Powder Exam Gloves
-Stretchy Vinyl Powder-free Exam Gloves

4. Are your factories certified with ISO 9001, ISO 13485 and comply with Good Manufacturing Practices (GMP) ?

Yes, all our factories are certified with ISO 9001, ISO 13485 and we manufacture our products strictly according to the GMP standards.

5. Do your gloves meet ASTM D3578 (for Latex Examination Gloves, ASTM D5250 (Vinyl Examination Gloves) and ASTM D3577(for Surgical Gloves) or EN 455/ EN 374 standards?

Yes, our gloves meet the said standards.

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