Biodegradable Powder Free Vinyl Examination Gloves Blue, Green And White Colors

Vinyl 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 Vinyl Examination Gloves Blue, Green And White Colors.

Pre-market Notification Details

Device IDK213144
510k NumberK213144
Device Name:Biodegradable Powder Free Vinyl Examination Gloves Blue, Green And White Colors
ClassificationVinyl 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 CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-27
Decision Date2021-12-22

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