Biodegradable Powder Free Nitrile Examination Glove, Green-White And Orange-White Colors With Low Dermatitis Potential Claim And Tested For Use With Chemotherapy Drugs, Fentanyl Citrate And Simulated Gastric Acid

Polymer Patient Examination Glove

Shen Wei USA Inc.

The following data is part of a premarket notification filed by Shen Wei Usa Inc. with the FDA for Biodegradable Powder Free Nitrile Examination Glove, Green-white And Orange-white Colors With Low Dermatitis Potential Claim And Tested For Use With Chemotherapy Drugs, Fentanyl Citrate And Simulated Gastric Acid.

Pre-market Notification Details

Device IDK202082
510k NumberK202082
Device Name:Biodegradable Powder Free Nitrile Examination Glove, Green-White And Orange-White Colors With Low Dermatitis Potential Claim And Tested For Use With Chemotherapy Drugs, Fentanyl Citrate And Simulated Gastric Acid
ClassificationPolymer Patient Examination Glove
Applicant Shen Wei USA Inc. 33278 Central Ave Ste 102 Union City,  CA  94587
ContactCheryl Reep
CorrespondentCheryl Reep
Shen Wei USA Inc. 33278 Central Ave Ste 102 Union City,  CA  94587
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-27
Decision Date2021-03-17

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