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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name polymer patient examination glove
510(k) Number K213141
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
Applicant
Shen Wei USA Inc.
33278 Central Ave. Suite 102
Union City,  CA  94587
Applicant Contact Cheryl Reep
Correspondent
Shen Wei USA Inc.
33278 Central Ave. Suite 102
Union City,  CA  94587
Correspondent Contact Cheryl Reep
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/27/2021
Decision Date 05/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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