POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR

Polymer Patient Examination Glove

PLATINUM GLOVE INDUSTRIES SDN.BHD.

The following data is part of a premarket notification filed by Platinum Glove Industries Sdn.bhd. with the FDA for Polymer Coated Powder Free Nitrile Examination Gloves, Blue, Green And White Color.

Pre-market Notification Details

Device IDK051317
510k NumberK051317
Device Name:POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR
ClassificationPolymer Patient Examination Glove
Applicant PLATINUM GLOVE INDUSTRIES SDN.BHD. 4015A, FL 4,PRESIDENT HSE, JLN SULTAN ISMAIL Kuala Lumpur,  MY 50250
ContactSo Soon Cheaw
CorrespondentSo Soon Cheaw
PLATINUM GLOVE INDUSTRIES SDN.BHD. 4015A, FL 4,PRESIDENT HSE, JLN SULTAN ISMAIL Kuala Lumpur,  MY 50250
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-20
Decision Date2005-06-20
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.