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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 K890987
Device Name VINYL PATIENT EXAMINATION GLOVE
Applicant
Jm Gloves Co., Ltd.
48, Kong Yeh Rd., Ur-Chen
Chuan,Kuan Tien
Shiang, Tainan Hsien,  TW 720
Applicant Contact TAMMY PHONE
Correspondent
Jm Gloves Co., Ltd.
48, Kong Yeh Rd., Ur-Chen
Chuan,Kuan Tien
Shiang, Tainan Hsien,  TW 720
Correspondent Contact TAMMY PHONE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/01/1989
Decision Date 04/06/1989
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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