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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 K100977
Device Name PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE
Applicant
Jiangsu Sunshine Plastic Products, Co., Ltd.
#45 Minsheng Rd., Danshui Twn
Taipei County,  TW 251
Applicant Contact MICHAEL LEE
Correspondent
Jiangsu Sunshine Plastic Products, Co., Ltd.
#45 Minsheng Rd., Danshui Twn
Taipei County,  TW 251
Correspondent Contact MICHAEL LEE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/08/2010
Decision Date 08/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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