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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 K210375
Device Name Powder Free Blue Nitrile Examination Glove
Applicant
Duramitt Sdn Bhd
# 3, Jalen Baling Padong Meha Industrial Estate
Padang Serai
Kulim,  MY 09400
Applicant Contact Terence Lim
Correspondent
Duramitt Sdn Bhd
# 3, Jalen Baling Padong Meha Industrial Estate
Padang Serai
Kulim,  MY 09400
Correspondent Contact Terence Lim
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/08/2021
Decision Date 06/21/2021
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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