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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 K001165
Device Name POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
Medipure Corporation (M) Sdn. Bhd.
No: 14, Jalan Taiping
Kuala Kangsar, Perak,  MY 33000
Applicant Contact LEE SON HONG
Correspondent
Medipure Corporation (M) Sdn. Bhd.
No: 14, Jalan Taiping
Kuala Kangsar, Perak,  MY 33000
Correspondent Contact LEE SON HONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/10/2000
Decision Date 07/05/2000
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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