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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 K932702
Device Name ULTAR-SHIELD
Applicant
Medical Resources International, Inc.
1201 Old Hopewell Rd.
Tampa,  FL  33619
Applicant Contact GENE CABRERA
Correspondent
Medical Resources International, Inc.
1201 Old Hopewell Rd.
Tampa,  FL  33619
Correspondent Contact GENE CABRERA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/03/1993
Decision Date 03/07/1994
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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