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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K212804
Device Name Powder free nitrile examination glove- blue, non-sterile
Applicant
Hong Seng Gloves Sdn Bhd
Lot 97, Jalan 10, Kawasan Perusahaan Bakar Arang
Sungai Petani,  MY 08000
Applicant Contact Ho Chia Yao
Correspondent
Emergo Global Representative, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Michael Van Der Woude
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/02/2021
Decision Date 12/01/2021
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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