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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 K891700
Device Name BODYGUARD PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Diamond Brothers Trading Co., Inc.
1663 Iowa St.
Costa Mesa,  CA  92626
Applicant Contact PATRICK A LOHAN
Correspondent
Diamond Brothers Trading Co., Inc.
1663 Iowa St.
Costa Mesa,  CA  92626
Correspondent Contact PATRICK A LOHAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/20/1989
Decision Date 04/27/1989
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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