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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K213144
Device Name Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
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
LYZ  
Date Received09/27/2021
Decision Date 12/22/2021
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
Predetermined Change
Control Plan Authorized		 No
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