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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 K213775
Device Name Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves
Applicant
Avecena Gloves Sdn Bhd
Lot 50592 Sendayan Techvalley Bandar Sri Sendayan Seremban
Negeri Sembilan,  MY 71950
Applicant Contact Mohd Aswad bin Ramli
Correspondent
Medcer Uluslararasi Medikal Belgelendirme Anonim Sirketi
Mevlana Bulvari No:221/141 Yildirim Kule
Ankara,  TR 06830
Correspondent Contact Mehmet Fatih Ormeci
Regulation Number880.6250
Classification Product Code
LYY  
Subsequent Product Code
LZA  
Date Received12/02/2021
Decision Date 04/24/2022
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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