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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K892302
Device Name NON-STERILE PATIENT EXAMINATION GLOVES
Applicant
Yeou-Fwu Rubber Industrial Co., Ltd.
289, Way Chung St.,Way Chung
Tsuen,Fuhin
Shiang,Chang Huahsie,  TW
Applicant Contact WAN-FWU CHANG
Correspondent
Yeou-Fwu Rubber Industrial Co., Ltd.
289, Way Chung St.,Way Chung
Tsuen,Fuhin
Shiang,Chang Huahsie,  TW
Correspondent Contact WAN-FWU CHANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/06/1989
Decision Date 04/28/1989
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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