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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 K024081
Device Name DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
Applicant
Safehealth Medical Supply Corp.
# 1,Tou Kang Li,
Hsueh Chia County
Tainan Hsien,  TW
Applicant Contact P.M. YEH
Correspondent
Safehealth Medical Supply Corp.
# 1,Tou Kang Li,
Hsueh Chia County
Tainan Hsien,  TW
Correspondent Contact P.M. YEH
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/11/2002
Decision Date 01/28/2003
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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