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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 K891878
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Pacific Delta Medical Supply
2386 Fair Oaks Blvd.
Sacramento,  CA  95825
Applicant Contact LA PORTE
Correspondent
Pacific Delta Medical Supply
2386 Fair Oaks Blvd.
Sacramento,  CA  95825
Correspondent Contact LA PORTE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/28/1989
Decision Date 06/02/1989
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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