Latex Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove And Tested For Use With Chemotherapy Drugs

Surgeon's Gloves

Hartalega NGC SDN. BHD.

The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Latex Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove And Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK214074
510k NumberK214074
Device Name:Latex Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove And Tested For Use With Chemotherapy Drugs
ClassificationSurgeon's Gloves
Applicant Hartalega NGC SDN. BHD. No. 1 Persiaran Tanjung Sepang,  MY 43900
ContactKuan Mun Leong
CorrespondentNurul Aisyah Kong
Hartalega NGC SDN. BHD. No. 1 Persiaran Tanjung Sepang,  MY 43900
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-27
Decision Date2022-05-26

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