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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 K891840
Device Name VINYL EXAMINATION GLOVES
Applicant
Maxcare, Inc.
5, Yu Liu Rd.
Youth Industrial Park
Tachia, Taiwan, R.O.C.,  TW
Applicant Contact ARNO PHUNG
Correspondent
Maxcare, Inc.
5, Yu Liu Rd.
Youth Industrial Park
Tachia, Taiwan, R.O.C.,  TW
Correspondent Contact ARNO PHUNG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/28/1989
Decision Date 07/14/1989
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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