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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 K932054
Device Name VINYL EXAMINATION GLOVES
Applicant
Assured Medical Supply Co., Ltd.
# 2-1, Kong Yeh N. Rd.,
Urchen Chuan, Kuan Tien Shiang
Tainan,  TW
Applicant Contact CHRISTIANA CHIEN
Correspondent
Assured Medical Supply Co., Ltd.
# 2-1, Kong Yeh N. Rd.,
Urchen Chuan, Kuan Tien Shiang
Tainan,  TW
Correspondent Contact CHRISTIANA CHIEN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/26/1993
Decision Date 06/30/1994
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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