Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black And Green Colors With Protein Content Labeling Claim (50 Micrograms Or Less)

Latex 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 Latex Examination Gloves Natural, Blue, Black And Green Colors With Protein Content Labeling Claim (50 Micrograms Or Less).

Pre-market Notification Details

Device IDK211620
510k NumberK211620
Device Name:Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black And Green Colors With Protein Content Labeling Claim (50 Micrograms Or Less)
ClassificationLatex 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 CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-26
Decision Date2021-08-19

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