FDA 510(k)

Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors

Número K: K202076 · 2021-03-05

Data da decisão2021-03-05

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2021-03-05 under 510(k) number K202076. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors?

Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K202076.

When did Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors receive FDA 510(k) clearance?

Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors received FDA 510(k) clearance on 2021-03-05, under 510(k) number K202076.

Who is the listed applicant for Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors?

The FDA 510(k) record lists Shen Wei USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors?

The FDA product code for Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors is LZA.

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Outros registros que listam Shen Wei USA, Inc. como candidato(a)

K213141Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution K213142Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution K213144Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors K211620Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)K211455Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors K202085Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green

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