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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 K892963
Device Name PATIENT EXAMINATION GLOVES
Applicant
Mao Gang Industrial Co.
11286 Grooms Rd.
Cincinnati,  OH  45242
Applicant Contact JOSEPH HARRIS
Correspondent
Mao Gang Industrial Co.
11286 Grooms Rd.
Cincinnati,  OH  45242
Correspondent Contact JOSEPH HARRIS
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1989
Decision Date 08/31/1989
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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