PT SYNTHETIC MEDICAL GLOVES, POWDER FREE

Vinyl Patient Examination Glove

SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD.

The following data is part of a premarket notification filed by Shanghai Pt Plastics Enterprise Company, Ltd. with the FDA for Pt Synthetic Medical Gloves, Powder Free.

Pre-market Notification Details

Device IDK963751
510k NumberK963751
Device Name:PT SYNTHETIC MEDICAL GLOVES, POWDER FREE
ClassificationVinyl Patient Examination Glove
Applicant SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD. NO. 268, YUSHU ROAD CANGQIAO TOWNSHIP Songjiang County Shanghai,  CN
ContactPeter Wang
CorrespondentPeter Wang
SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD. NO. 268, YUSHU ROAD CANGQIAO TOWNSHIP Songjiang County Shanghai,  CN
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-18
Decision Date1996-10-29

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