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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 K963514
Device Name PACER PLUS SYNTHETIC MEDICAL VINLY PATIENT EXAMINATION GLOVES (POWDERED)
Applicant
Shanghai PM Plastics Enterise Co., Ltd.
# 258,W.Yushu Rd.& S.Hu-Hang
Railway, Cangqiao Township
Songjiang Co., Shanghai,  CN
Applicant Contact CHANG TE SUN
Correspondent
Shanghai PM Plastics Enterise Co., Ltd.
# 258,W.Yushu Rd.& S.Hu-Hang
Railway, Cangqiao Township
Songjiang Co., Shanghai,  CN
Correspondent Contact CHANG TE SUN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/03/1996
Decision Date 10/24/1996
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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