Powder-Free Nitrile Examination Glove, Non-Sterile

Polymer Patient Examination Glove

GoodGloves Industries Sdn Bhd

The following data is part of a premarket notification filed by Goodgloves Industries Sdn Bhd with the FDA for Powder-free Nitrile Examination Glove, Non-sterile.

Pre-market Notification Details

Device IDK221877
510k NumberK221877
Device Name:Powder-Free Nitrile Examination Glove, Non-Sterile
ClassificationPolymer Patient Examination Glove
Applicant GoodGloves Industries Sdn Bhd PT 12678, Jalan Techvalley 2, Sendayan Techvalley Bandar Sri Sendayan Seremban,  MY 71950
ContactYee Kam Lin
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2022-06-28
Decision Date2022-07-23

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