POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE

Polymer Patient Examination Glove

BETTER CARE PLASTIC TECHNOLOGY CP., LTD

The following data is part of a premarket notification filed by Better Care Plastic Technology Cp., Ltd with the FDA for Powder Free Nitrile Patient Examination Gloves, Blue.

Pre-market Notification Details

Device IDK101594
510k NumberK101594
Device Name:POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
ClassificationPolymer Patient Examination Glove
Applicant BETTER CARE PLASTIC TECHNOLOGY CP., LTD 3973 SCHAEFER AVE Chino,  CA  91710
ContactJie Liu\
CorrespondentJie Liu\
BETTER CARE PLASTIC TECHNOLOGY CP., LTD 3973 SCHAEFER AVE Chino,  CA  91710
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-08
Decision Date2010-10-08
Summary:summary

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