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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 K022604
Device Name POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
Applicant
Sun Flower Gloves Co., Ltd.
187 Chien-Yeh Rd., Shanhua
Tainan Hsien,  TW 74103
Applicant Contact W. J. HU
Correspondent
Sun Flower Gloves Co., Ltd.
187 Chien-Yeh Rd., Shanhua
Tainan Hsien,  TW 74103
Correspondent Contact W. J. HU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/06/2002
Decision Date 10/25/2002
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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