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Nitrile Disposable Medical Glove CE/FDA 510K Listing ($0 ...

Material: Nitrile Gloves, 100% Latex Free, No allergy. Application: Widely used in medical examination, dentistry, first-aid, healthcare, etc. More exceeding feature of puncture-resistance, anti-bacteria’s penetration, chemical-proof. Durable & Flexible, Surface-textured, Soft feeling, Comfortable donning. The tapered cuff is easy for donning ...

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Nitrile Gloves 510K – International Consumer Corporation

Nitrile Gloves 510K. SKU: 8-50018-92702-4 Category: Products. Description Additional information Reviews (0) Description. Made in Thailand. 4.7 mil thickness. Blue, with small quantity of green and purple color. 100 count boxes. 510K FDA medical certified. Sizes S, M, L. Arrives 25 June.

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Jun 14, 2021·510 (k) Number. K180644. Device Name. Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green. Applicant.

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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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