# K213893: Comfort Gown, Safewear Gown

- Pathway: 510(k) (Traditional)
- Applicant: Xuchang Zhengde Environstar Medical Products Co., Ltd.
- Decided: Dec 21, 2022 after 372 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
Longest line of descent: 5 generations back to K964142 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192290: 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown, Xuchang Zhengde Environstar Medical Products Co., Ltd. (2020) Summary page 6.
- K172987: Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001), Gmax Industries, Inc. (2018) Summary page 6.

## Indications for use
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Comfort Gown met the requirements for Level 1 and Level 2 Standard Surgical Gown classifications, and Safewear Gown met the requirements for Level 3 Standard Surgical Gown, Level 3 Standard Plus Surgical Gown, Level 3 Reinforced Surgical Gown and Level 3 Reinforced Plus Surgical Gown classifications. The gowns are provided sterile and non-sterile. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

Source page: https://510kreport.com/device/K213893
Methodology: https://510kreport.com/methodology