Biodegradable 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

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, 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.

Pre-market Notification Details

Device IDK213141
510k NumberK213141
Device Name:Biodegradable 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
ClassificationPolymer Patient Examination Glove
Applicant Shen Wei USA Inc. 33278 Central Ave. Suite 102 Union City,  CA  94587
ContactCheryl Reep
CorrespondentCheryl Reep
Shen Wei USA Inc. 33278 Central Ave. Suite 102 Union City,  CA  94587
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-27
Decision Date2022-05-28

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