BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free

Polymer Patient Examination Glove

Meditech Gloves SDN BHD

The following data is part of a premarket notification filed by Meditech Gloves Sdn Bhd with the FDA for Bpg Chemoplus Nitrile Patient Examination Gloves, Powder Free.

Pre-market Notification Details

Device IDK213408
510k NumberK213408
Device Name:BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free
ClassificationPolymer Patient Examination Glove
Applicant Meditech Gloves SDN BHD PT 3345, Jalan Permata 1/3, Arab Malaysian Industrial Park Nilai,  MY 71800
ContactEffendi Tenang
CorrespondentWan Nadzifah Wan Hassan
Meditech Gloves SDN BHD PT 3345, Jalan Permata 1/3, Arab Malaysian Industrial Park Nilai,  MY 71800
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-10-19
Decision Date2022-04-17

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