Powder Free Nitrile Examination Gloves (Blue)

Polymer Patient Examination Glove

KGM Gloves Sdn. Bhd.

The following data is part of a premarket notification filed by Kgm Gloves Sdn. Bhd. with the FDA for Powder Free Nitrile Examination Gloves (blue).

Pre-market Notification Details

Device IDK220284
510k NumberK220284
Device Name:Powder Free Nitrile Examination Gloves (Blue)
ClassificationPolymer Patient Examination Glove
Applicant KGM Gloves Sdn. Bhd. Lot 18893 & 18894, Jalan Perusahaan 9, Kawasan Perusahaan Kamunting,  MY 34600
ContactOoi Loon Seng
CorrespondentOoi Loon Seng
KGM Gloves Sdn. Bhd. Lot 18893 & 18894, Jalan Perusahaan 9, Kawasan Perusahaan Kamunting,  MY 34600
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-01
Decision Date2022-07-08

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