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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 K892110
Device Name PROTECTOR PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Brajatama, Inc.
1311 El Camino Real
Suite 260
Millbrae,  CA  94030
Applicant Contact JOHN CHANG
Correspondent
Brajatama, Inc.
1311 El Camino Real
Suite 260
Millbrae,  CA  94030
Correspondent Contact JOHN CHANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/03/1989
Decision Date 05/12/1989
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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