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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 K011995
Device Name POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
Quality Latex Products Malaysia Sdn Bhd
18-20, Jalan Kilang 2
Jelapang Light Indust. Estate
Ipoh. Perak,  MY 30100
Applicant Contact SHARENE WAN
Correspondent
Quality Latex Products Malaysia Sdn Bhd
18-20, Jalan Kilang 2
Jelapang Light Indust. Estate
Ipoh. Perak,  MY 30100
Correspondent Contact SHARENE WAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/26/2001
Decision Date 07/31/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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