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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 K974371
Device Name CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE
Applicant
Clk Intl., Inc.
28 E. Broadway, 2nd Floor
New York,  NY  10002
Applicant Contact GEORGE Q KUO
Correspondent
Clk Intl., Inc.
28 E. Broadway, 2nd Floor
New York,  NY  10002
Correspondent Contact GEORGE Q KUO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/20/1997
Decision Date 04/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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