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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 K910891
Device Name PVC VINYL GLOVE
Applicant
Pioneer Sundries Products , Ltd.
Rm. 1101-2 Arion Commercial
Center, 2-12 Queen'S Rd. W.
Hong Kong,  CN
Applicant Contact BRUCE A YUEN
Correspondent
Pioneer Sundries Products , Ltd.
Rm. 1101-2 Arion Commercial
Center, 2-12 Queen'S Rd. W.
Hong Kong,  CN
Correspondent Contact BRUCE A YUEN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/04/1991
Decision Date 03/11/1991
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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