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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 K010231
Device Name JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE
Applicant
Jk Gloves Sdn. Bhd.
Lot 26738 & 26740-K8 & P2
Jalan Tee Teck Sa
Senai, Johor,  MY 81400
Applicant Contact TAI SAI LEONG
Correspondent
Jk Gloves Sdn. Bhd.
Lot 26738 & 26740-K8 & P2
Jalan Tee Teck Sa
Senai, Johor,  MY 81400
Correspondent Contact TAI SAI LEONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/24/2001
Decision Date 02/09/2001
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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