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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 K904525
Device Name PATIENT EXAMINATION GLOVES
Applicant
Jian Win Latex Product Factory
55 Xi Quao Rd.,
Xing Chang Kat Ping County
Guang Dong Province China,  CN
Applicant Contact MISS MARGARET
Correspondent
Jian Win Latex Product Factory
55 Xi Quao Rd.,
Xing Chang Kat Ping County
Guang Dong Province China,  CN
Correspondent Contact MISS MARGARET
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/27/1990
Decision Date 10/12/1990
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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