# Hubei Xinxin Non-Woven Co., Ltd.

- Location (FDA's records): Xiantao, CN
- FDA decisions: 4 (2022–2026): 4 510(k) clearances
- Product codes: FYC (2), FXX (1), FYA (1)
- 510(k) review time since 2016: median 209 days, against 214 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- San-M Package Co., Ltd.: 1 (https://510kreport.com/company/san-m-package)
- Amd Medicom, Inc.: 1 (https://510kreport.com/company/amd-medicom)
- Fugou County Shenxiang Manufacturing Co., Ltd.: 1 (https://510kreport.com/company/fugou-county-shenxiang-manufacturing)

## Firms that cite its devices most
- Henan Yadu Industrial Co., Ltd.: 1 (https://510kreport.com/company/henan-yadu-industrial)

## Its most-cited devices
- K212120: Surgical Masks (2022), cited by 1

## Recent decisions
- K253003: Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) (Apr 20, 2026)
- K214116: AAMI4 Isolation Gown (Oct 11, 2022)
- K213832: AAMI3 Isolation Gown (May 16, 2022)
- K212120: Surgical Masks (Jan 28, 2022)

Source page: https://510kreport.com/company/hubei-xinxin-non-woven