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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 K211601
Device Name Powder Free Latex Examination Glove, Non-Sterile
Applicant
Wrp Asia Pacific Sdn. Bhd.
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi
Sepang,  MY 43900
Applicant Contact Siti Syamimie Atirah Binti Mat
Correspondent
Sg Global, LLC
3700 Massillon Rd.
Suite 340
Uniontown,  OH  44685
Correspondent Contact Saravanan Ramasamy
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/24/2021
Decision Date 08/22/2022
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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