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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 K891103
Device Name STERILE PATIENT EXAMINATION GLOVE
Applicant
Boston Medical Corp.
8350 Bristol Ct.
Suite 101
Jessup,  MD  20794
Applicant Contact TIMOTHY F HAND
Correspondent
Boston Medical Corp.
8350 Bristol Ct.
Suite 101
Jessup,  MD  20794
Correspondent Contact TIMOTHY F HAND
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/17/1989
Decision Date 03/14/1989
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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