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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 K003904
Device Name POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
Applicant
Purna Bina Sdn Bhd
Plo 5 Jln. Mahsuri 1,
Kawasan Perindustrain Kluang
Kluang, Jahor,  MY 86007
Applicant Contact LIEW YOON FONG
Correspondent
Purna Bina Sdn Bhd
Plo 5 Jln. Mahsuri 1,
Kawasan Perindustrain Kluang
Kluang, Jahor,  MY 86007
Correspondent Contact LIEW YOON FONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/19/2000
Decision Date 01/24/2001
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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