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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 K904190
Device Name PATIENT EXAMINATION GLOVES
Applicant
1st Med, Inc.
504 Railroad St.
Joliet,  IL  60436
Applicant Contact EDWARD J ROHN
Correspondent
1st Med, Inc.
504 Railroad St.
Joliet,  IL  60436
Correspondent Contact EDWARD J ROHN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/12/1990
Decision Date 09/19/1990
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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