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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patient Examination Glove
510(k) Number K781278
Device Name GLOVES, PROCEDURE
Applicant
Arbrook Mfg. Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Arbrook Mfg. Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6250
Classification Product Code
FMC  
Date Received07/25/1978
Decision Date 08/31/1978
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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