FDA 510(k)

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs

Número K: K173766 · 2018-07-08

Data da decisão2018-07-08

Código do produtoLZC

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs 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 2018-07-08 under 510(k) number K173766. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs?

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs is a medical device that received FDA 510(k) clearance on 2018-07-08. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K173766.

When did PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs receive FDA 510(k) clearance?

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs received FDA 510(k) clearance on 2018-07-08, under 510(k) number K173766.

Who is the listed applicant for PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs?

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 PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs?

The FDA product code for PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs is LZC.

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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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