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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 K891426
Device Name PROSHIELD GLOVE (LATEX)
Applicant
K & M Resources, Inc.
50 Millay Pl.
Mill Valley,  CA  94941
Applicant Contact D MONARDO
Correspondent
K & M Resources, Inc.
50 Millay Pl.
Mill Valley,  CA  94941
Correspondent Contact D MONARDO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/14/1989
Decision Date 04/26/1989
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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