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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 K001042
Device Name COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE
Applicant
Comfort Rubber Gloves Industries Sdn. Bhd.
Lot 821, Jalan Matang
Matang,  MY 34750
Applicant Contact CHEE YONG FOO
Correspondent
Comfort Rubber Gloves Industries Sdn. Bhd.
Lot 821, Jalan Matang
Matang,  MY 34750
Correspondent Contact CHEE YONG FOO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/31/2000
Decision Date 05/23/2000
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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