DISPOSABLE PVC SYNTHETIC EXAMINATION 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 Disposable Pvc Synthetic Examination Gloves, Powder Free.

Pre-market Notification Details

Device IDK001611
510k NumberK001611
Device Name:DISPOSABLE PVC SYNTHETIC EXAMINATION 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 Received2000-05-25
Decision Date2000-06-30

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