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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 K062965
Device Name CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
Applicant
Kossan Latex Industries(M)Sdn Bhd
2530 Riva Rd., Suite 308
Annapolis,  MD  21401
Applicant Contact JAMES F LOGAN
Correspondent
Kossan Latex Industries(M)Sdn Bhd
2530 Riva Rd., Suite 308
Annapolis,  MD  21401
Correspondent Contact JAMES F LOGAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/29/2006
Decision Date 12/22/2006
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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