# K121998: HM Surgical Gown, Non Reinforced HM Surgical Gown, Fabric Reinforced HM Surgical Gown, Polyerinforced

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Holymed Products Co., Ltd.
- Decided: Dec 20, 2012 after 164 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
HM Surgical gowns are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of micro-organisms, body fluids, and particulate mailer. NM Surgical Gowns are disposable, single use, sterile or nonsterile surgical gowns manufactured from non-woven Spunbond-Meltblowri-Spunbond (SMS) polypropylene fabrics. Non-sterile HM surgical gowns ame to be sold to repackagerlrelabeler establishments for EtO sterilization according to ISO 11135-1 and Sterile surgical gowns are to be said directly to users after EtO sterilization validation to ISO 11135-1. Gowns are provided as below

Source page: https://510kreport.com/device/K121998
Methodology: https://510kreport.com/methodology