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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 K092301
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK)
Applicant
Bettercare Plastic Products Co., Ltd.
3973 Schaefer Ave.,
Chino,  CA  91710
Applicant Contact JIE LIU
Correspondent
Bettercare Plastic Products Co., Ltd.
3973 Schaefer Ave.,
Chino,  CA  91710
Correspondent Contact JIE LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/29/2009
Decision Date 10/22/2009
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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