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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 K211360
Device Name Disposable Nitrile Powder Free Examination Gloves (Non-sterile)
Applicant
Pt. Universal Gloves
Jl. Patumbak #17 Patumbak
Medan,  ID 20361
Applicant Contact Sutopo Sutopo
Correspondent
Ammex Corporation
1019 W James St. #200
Kent,  WA  98032
Correspondent Contact Sasitharan Nair
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/03/2021
Decision Date 01/15/2022
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
Predetermined Change
Control Plan Authorized		 No
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