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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 K930266
Device Name VINYL EXAMINATION GLOVES
Applicant
Shanghai PM Plastics Enterise Co., Ltd.
# 258,W.Yushu Rd.& S.Hu-Hang
Railway, Cangqiao Township
Songjiang Co., Shanghai,  CN
Applicant Contact WANG CHIEN-SHUN
Correspondent
Shanghai PM Plastics Enterise Co., Ltd.
# 258,W.Yushu Rd.& S.Hu-Hang
Railway, Cangqiao Township
Songjiang Co., Shanghai,  CN
Correspondent Contact WANG CHIEN-SHUN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received01/19/1993
Decision Date 11/22/1993
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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