Nitrile Patient Examination Gloves, Powder Free

Polymer Patient Examination Glove

Lalan Rubbers (Pvt) Ltd

The following data is part of a premarket notification filed by Lalan Rubbers (pvt) Ltd with the FDA for Nitrile Patient Examination Gloves, Powder Free.

Pre-market Notification Details

Device IDK220697
510k NumberK220697
Device Name:Nitrile Patient Examination Gloves, Powder Free
ClassificationPolymer Patient Examination Glove
Applicant Lalan Rubbers (Pvt) Ltd No.95/B, Zone A, Export Processing Zone, Biyagama Malwana,  LK EPZ 11672
ContactRenuka Priyangi
CorrespondentRenuka Priyangi
Lalan Rubbers (Pvt) Ltd No.95/B, Zone A, Export Processing Zone, Biyagama Malwana,  LK EPZ 11672
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-09
Decision Date2022-09-15

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