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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 K021536
Device Name DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR
Applicant
Wrp Specialty Products Sdn. Bhd.
Baru Salak
Tinggi 43900 Sepang
Selangor Darul Ehsan,  MY
Applicant Contact V. NADARAJAN
Correspondent
Wrp Specialty Products Sdn. Bhd.
Baru Salak
Tinggi 43900 Sepang
Selangor Darul Ehsan,  MY
Correspondent Contact V. NADARAJAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/10/2002
Decision Date 06/10/2002
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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