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

Surgeon's Gloves

Hartalega SDN BHD

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

Pre-market Notification Details

Device IDK201748
510k NumberK201748
Device Name:Latex Powder Free Surgical Glove With Protein Labelling Claim Of 50 Microgram Or Less Per Gram Of Glove And Tested For Use With Chemotherapy Drugs
ClassificationSurgeon's Gloves
Applicant Hartalega SDN BHD Dataran SD PJU 9 Bandar Sri Damansara,  MY 52200
ContactKuan Kam Hon
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-06-26
Decision Date2020-10-02

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