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CE/ FDA 510K INTCO medical nitrile examination gloves

• FDA 510(K) Available • Approved to use with Chemotherapy Drugs 1.100% latex free-made from durable,puncture resistant, protein and powder- free nitrile,eliminates the Type I allergic reaction associated with natural rubber latex 2.Highly elastic and super soft 3.Rolled rim to facillitate easy donning 4.Designed to give a natural rubber ...

510(k) Premarket Notification

Jan 25, 2021·510(k) Number: K162405: Device Name: Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) Applicant: COMFORT RUBBER GLOVES INDUSTRIES SDN BHD: LOT 821, JALAN MATANG:

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Nitrile is perfect for demanding applications, especially cleaning and dishwashing. Our lightly powdered versions are produced with a food grade corn starch powder, making it easier to take them on or off – especially with wet hands. Powder free gloves go through an extra process of chlorinating the gloves …

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A 510 k clearance is mandatory for examination and surgical gloves to market in the USA. FDA review time for a 510 k notification is 3 months, but in reality, it may take 6 months or more depends how perfect your 510k documentation is. FDA published guidance documents for latex and nitrile (examination and surgical) gloves 510k submission.

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CTI’s NCP Series Nitrile Co-Polymer Powder Free Class 100 Gloves are manufactured for outstanding strength, stretch and fit. They offer a textured surface and a super soft feel for comfort. NCP Series Class 100 Nitrile gloves ISO 5 Clean Room compatible or higher controlled environments. They…

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510(k) Premarket Notification

Jan 25, 2021·510(k) Number: K162405: Device Name: Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) Applicant: COMFORT RUBBER GLOVES INDUSTRIES SDN BHD: LOT 821, JALAN MATANG:

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PROSAFE powder free gloves are ideal for individuals hypersensitive to protein in latex gloves. Thanks to our unique process of hot water and Chlorine cleaning, our powder-free gloves have extremely low levels of extractable protein. We also provide a range of gloves for general purpose on OEM basis.

Nitrile Gloves - FDA 510K, CE-Class 3, ASTM-D-3578, ISO13485

Medical Nitrile Examination Gloves with FDA 410K, CE-Class 3, ASTM-D-3578, EC MARK FOR MEDICAL DEVICES UE 2017/745, and ISO13485.

Nitrile Gloves , Edge Brand 510K , En 374 by Cong Ty Tnhh ...

Non-Sterile Medical Examination Nitrile Gloves Powder free & Latex free 100% Virgin raw materials with FDA certificate & as per ASTM D6319/ CE EN 455 Quality standard: ASTM D6319, with 510K and FDA, CE/EN455, Color: Blue, white Finger Tips: textured Cuff: Beaded Pcs per Box for S/M/L/XL : 100pcs/box Origin: China, Vietnam, Thailand, Malaysia Benefits Protection from unwanted and …

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