# K230610: Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Shin YI Healthcare Products Factory
- Decided: Aug 23, 2023 after 170 days
- Product code: FYA (Gown, 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
Disposable Surgical Gown (Level 3, MF2103 Series)/ Disposable Surgical Gown (Level 3, MF2104 Series)/ Disposable Surgical Gown (Level 4, MF2105 Series) is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is single use, disposable and supplied sterile. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, MF2103 Series and MF2104 Series met the requirements for Level 3 classification, MF2105 Series met the requirements of Level 4 classification. Models information: MF2103 Series: MF21031A1, MF21032A1, MF21033A1, MF21034A1, MF21035Al; MF2104 Series: MF21041A1, MF21042A1, MF21043A1, MF21044A1, MF21045A1; MF2105 Series: MF21051A1, MF21052A, MF21053A1, MF21054A1, MF21055Al.

Source page: https://510kreport.com/device/K230610
Methodology: https://510kreport.com/methodology