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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K963751
Device Name PT SYNTHETIC MEDICAL GLOVES, POWDER FREE
Applicant
Shanghai PT Plastics Enterprise Company, Ltd.
# 268, Yushu Rd.
Cangqiao Township
Songjiang County Shanghai,  CN
Applicant Contact PETER WANG
Correspondent
Shanghai PT Plastics Enterprise Company, Ltd.
# 268, Yushu Rd.
Cangqiao Township
Songjiang County Shanghai,  CN
Correspondent Contact PETER WANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/18/1996
Decision Date 10/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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