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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 K041004
Device Name ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE)
Applicant
Purna Bina Sdn Bhd
Plo 5, Jalan Mahsuri 1, 7.5km
J. Mersing, Kluang Ind. Area
Kluang, Johor D. Takzim,  MY 86000
Applicant Contact LIEW YOON FONG
Correspondent
Purna Bina Sdn Bhd
Plo 5, Jalan Mahsuri 1, 7.5km
J. Mersing, Kluang Ind. Area
Kluang, Johor D. Takzim,  MY 86000
Correspondent Contact LIEW YOON FONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/19/2004
Decision Date 07/02/2004
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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