Powder Free Nitrile Examination Gloves, Blue, Tested For Use With Chemotherapy Drugs

Patient Examination Glove, Specialty

HL Rubber Industries Sdn Bhd

The following data is part of a premarket notification filed by Hl Rubber Industries Sdn Bhd with the FDA for Powder Free Nitrile Examination Gloves, Blue, Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK220545
510k NumberK220545
Device Name:Powder Free Nitrile Examination Gloves, Blue, Tested For Use With Chemotherapy Drugs
ClassificationPatient Examination Glove, Specialty
Applicant HL Rubber Industries Sdn Bhd Lot 10, Kawasan Perindustrian Dioh, Kuala Pilah,  MY 72000
ContactNoorzaliza Ahmad
CorrespondentNoorzaliza Ahmad
HL Rubber Industries Sdn Bhd Lot 10, Kawasan Perindustrian Dioh, Kuala Pilah,  MY 72000
Product CodeLZC  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-25
Decision Date2022-05-26

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