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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 K914628
Device Name PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF
Applicant
Medical Resources, Ltd.
520 W. Brannen Rd.
Lakeland,  FL  33813
Applicant Contact RICHARD H GHENN
Correspondent
Medical Resources, Ltd.
520 W. Brannen Rd.
Lakeland,  FL  33813
Correspondent Contact RICHARD H GHENN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/13/1991
Decision Date 11/07/1991
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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