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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 K891067
Device Name PATIENT EXAMINATION GLOVE, VINYL
Applicant
Sun Flower Gloves Co., Ltd.
187, Chien-Eyh Rd.
Shan-Hua, 74103
Tainan Hsien, Taiwan,  TW
Applicant Contact W. J HU
Correspondent
Sun Flower Gloves Co., Ltd.
187, Chien-Eyh Rd.
Shan-Hua, 74103
Tainan Hsien, Taiwan,  TW
Correspondent Contact W. J HU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/01/1989
Decision Date 03/23/1989
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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