Sterile Nitrile Surgical Powder Free Gloves Tested For Use With Chemotherapy Drugs And Sterile Latex Surgical Powder Free Gloves

Surgeon's Gloves

Top Glove SDN BHD

The following data is part of a premarket notification filed by Top Glove Sdn Bhd with the FDA for Sterile Nitrile Surgical Powder Free Gloves Tested For Use With Chemotherapy Drugs And Sterile Latex Surgical Powder Free Gloves.

Pre-market Notification Details

Device IDK171279
510k NumberK171279
Device Name:Sterile Nitrile Surgical Powder Free Gloves Tested For Use With Chemotherapy Drugs And Sterile Latex Surgical Powder Free Gloves
ClassificationSurgeon's Gloves
Applicant Top Glove SDN BHD Lot 4968, Jalan Teratai, Batu 6, Off Jalan Meru Klang,  MY 41050
ContactNoor Akilah Bt Saidin
CorrespondentNoor Akilah Bt Saidin
Top Glove SDN BHD Lot 4968, Jalan Teratai, Batu 6, Off Jalan Meru Klang,  MY 41050
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-01
Decision Date2017-10-12

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