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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 K895941
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Gim'S Trading Corp.
160-42 21st Rd.
Whitestone,  NY  11357
Applicant Contact PHIL GIM
Correspondent
Gim'S Trading Corp.
160-42 21st Rd.
Whitestone,  NY  11357
Correspondent Contact PHIL GIM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/11/1989
Decision Date 03/08/1990
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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