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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 K895499
Device Name POLY-FLEX LATEX EXAMINATION GLOVES
Applicant
Pacific Delta Medical Supply
2386 Fair Oaks Blvd.
Sacramento,  CA  95825
Applicant Contact RON LAPORTE
Correspondent
Pacific Delta Medical Supply
2386 Fair Oaks Blvd.
Sacramento,  CA  95825
Correspondent Contact RON LAPORTE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/06/1989
Decision Date 11/16/1989
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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