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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 K030157
Device Name POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM
Applicant
Wrp Asia Pacific Sdn. Bhd.
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi
Sepang,  MY 43900
Applicant Contact TERENCE LIM
Correspondent
Wrp Asia Pacific Sdn. Bhd.
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi
Sepang,  MY 43900
Correspondent Contact TERENCE LIM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/16/2003
Decision Date 02/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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