Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile 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 Examination Gloves (non-sterile), Disposable Nitrile Examination Gloves (non-sterile).

Pre-market Notification Details

Device IDK203074
510k NumberK203074
Device Name:Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)
ClassificationLatex Patient Examination Glove
Applicant PT. Universal Gloves Jl. Pertahanan No. 17 Patumbak Medan,  ID 20361
ContactLi I-feng
CorrespondentI-feng Li
PT. Universal Gloves Jl. Pertahanan No. 17 Patumbak Medan,  ID 20361
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-09
Decision Date2021-11-19

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