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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 K973902
Device Name VINYL PATIENT EXAMINATION GLOVES POWDERED
Applicant
Everrise Glove Products Co., Ltd.
# 47 Huan Kung Rd., Wang Haun
Li, Yung Kang City
Tainan Hsien,  TW 710
Applicant Contact JASON CHANG
Correspondent
Everrise Glove Products Co., Ltd.
# 47 Huan Kung Rd., Wang Haun
Li, Yung Kang City
Tainan Hsien,  TW 710
Correspondent Contact JASON CHANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/14/1997
Decision Date 11/18/1997
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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