Powder Free Nitrile Examination Glove

Polymer Patient Examination Glove

Pastel Glove Sdn Bhd

The following data is part of a premarket notification filed by Pastel Glove Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove.

Pre-market Notification Details

Device IDK210369
510k NumberK210369
Device Name:Powder Free Nitrile Examination Glove
ClassificationPolymer Patient Examination Glove
Applicant Pastel Glove Sdn Bhd PT285724, Jalan Pusing, Taman Perindustrian Perabot Negeri Park Pusing,  MY 31550
ContactSiou Wei Law
CorrespondentTerence Lim
Pastel Glove Sdn Bhd PT285724, Jalan Pusing, Taman Perindustrian Perabot Negeri Park Pusing,  MY 31550
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-08
Decision Date2021-05-13

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