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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 K955091
Device Name DISPOSABLE POWDER FREE VINYL SYNTHETIC GLOVES
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 Received11/07/1995
Decision Date 12/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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