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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 K891855
Device Name WINFIELD LATEX EXAMINATION GLOVES
Applicant
Winfield Co., Inc.
2690 Harrison St.
San Francisco,  CA  94110
Applicant Contact NELSON SHUM
Correspondent
Winfield Co., Inc.
2690 Harrison St.
San Francisco,  CA  94110
Correspondent Contact NELSON SHUM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/27/1989
Decision Date 06/22/1989
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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