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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 K221877
Device Name Powder-Free Nitrile Examination Glove, Non-Sterile
Applicant
GoodGloves Industries Sdn Bhd
PT 12678, Jalan Techvalley 2, Sendayan Techvalley
Bandar Sri Sendayan
Seremban,  MY 71950
Applicant Contact Yee Kam Lin
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/28/2022
Decision Date 07/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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