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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name surgeon's gloves
510(k) Number K203030
Device Name POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Applicant
WRP ASIA PACIFIC SDN BHD
Lot 1 Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi
Sepang,  MY 43900
Applicant Contact Saravanan Ramasamy
Correspondent
WRP USA INC
Lot 1, Jalan 3, Kawasan Perusahaan Bandar
Baru Salak Tinggi
Sepang, Selangor Darul Ehsan,  MY 43900
Correspondent Contact Saravanan Ramasamy
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received10/02/2020
Decision Date 06/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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