Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color

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 Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-black Color.

Pre-market Notification Details

Device IDK202080
510k NumberK202080
Device Name:Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color
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 Date2021-03-24

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