510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K210148Substantially Equivalent

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)

Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti., Istanbul, TR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K210148 is the FDA 510(k) clearance record for 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), a class II device, cleared for Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. on under FDA product code FYC (Gown, Isolation, Surgical). FDA records list one 510(k) clearance for Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. As of , FDA records show no recalls naming K210148.

Clearance record

Decision date
Received
(447 days to decision)
Product code
FYC Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. Beysan Sanayi Sitesi, Dereboyu Caddesi., Istanbul, TR
510(k) summary
Statement
Third party review
No

Clearances, product code FYC

Trailing 12 months

FDA records hold no clearances under product code FYC in the trailing twelve months.

FDA records show no clearances under product code FYC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FYC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260