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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K210148
Device Name Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)
Applicant
Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.
Beysan Sanayi Sitesi, Dereboyu Caddesi.
No 26 Kat: 3 Beylikduzu
Istanbul,  TR 34524
Applicant Contact Alaattin Saz
Correspondent
Mansour Consulting, LLC
845 Aronson Lake Ct.
Roswell,  GA  30075
Correspondent Contact Jay Mansour
Regulation Number878.4040
Classification Product Code
FYC  
Date Received01/21/2021
Decision Date 04/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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