ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET

Polymer Patient Examination Glove

PROFIT POINT MANUFACTURING SDN BHD

The following data is part of a premarket notification filed by Profit Point Manufacturing Sdn Bhd with the FDA for Elegant Nitrile Powder Free Examination Glove Blue Violet.

Pre-market Notification Details

Device IDK120110
510k NumberK120110
Device Name:ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET
ClassificationPolymer Patient Examination Glove
Applicant PROFIT POINT MANUFACTURING SDN BHD LOT PTD 27735 (PLO 9) 26624 (PLO 18) Kluang,  MY 86000
ContactRobert Hill
CorrespondentRobert Hill
PROFIT POINT MANUFACTURING SDN BHD LOT PTD 27735 (PLO 9) 26624 (PLO 18) Kluang,  MY 86000
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-13
Decision Date2012-10-04

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