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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 K093797
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE)
Applicant
Supermax Plastic Products Co., Ltd.
3973 Schaefer Ave.,
Chino,  CA  91710
Applicant Contact JIE LIU
Correspondent
Supermax Plastic Products Co., Ltd.
3973 Schaefer Ave.,
Chino,  CA  91710
Correspondent Contact JIE LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/10/2009
Decision Date 02/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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