Disposable Latex Powder Free Examination Gloves (Non-sterile)

Latex Patient Examination Glove

PT. Universal Gloves

The following data is part of a premarket notification filed by Pt. Universal Gloves with the FDA for Disposable Latex Powder Free Examination Gloves (non-sterile).

Pre-market Notification Details

Device IDK201576
510k NumberK201576
Device Name:Disposable Latex Powder Free Examination Gloves (Non-sterile)
ClassificationLatex Patient Examination Glove
Applicant PT. Universal Gloves JL. Pertahanan No.17 Patumbak Medan,  ID 20361
ContactSutopo Sutopo
CorrespondentSasitharan Nair
Ammex Corporation 1019 W James St #200, 98032, United States Kent,  WA  98032
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-11
Decision Date2021-05-19

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