# K210148: 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)

- Pathway: 510(k) (Traditional)
- Applicant: Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.
- Decided: Apr 13, 2022 after 447 days
- Product code: FYC (Gown, Isolation, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Flosteril Poly-Reinforced Isolation Gowns, Model 8120 (Catalogue Numbers 8120400, 8120410, 8120430, 8120450, 8120460) is intended to be worn by healthcare personnel to protect patients and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. Flosteril Poly-Reinforced Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70) It is a single use, disposable medical device provided non-sterile and not intended for use in operating rooms. The medical device will be available in 15 models in Large, X Large and XX Large sizes. Catalogue number | Specific attributes | REF (L; XL; XXL) 8120400 | Hook and loop; Knitted cuff; collar lace; tag | FLS 10401; FLS 10402; FLS 10403 8120410 | Hook and loop; elastic band; collar lace; tag | FLS 10411; FLS 10412; FLS 10413 8120430 | Knitted cuff; tie; collar lace; tag | FLS 10431; FLS 10432; FLS 10433 8120450 | Elastic band; sticky tab; tag | FLS 10451; FLS 10452; FLS 10453 8120460 | Elastic band; thumb loop cuff; sticky tab; tag | FLS 10461; FLS 10462; FLS 10463

Source page: https://510kreport.com/device/K210148
Methodology: https://510kreport.com/methodology