# Haian Medigauze Co., Ltd.

- Location (FDA's records): Nantong, CN
- FDA decisions: 1 (2021–2021): 1 510(k) clearance
- Product codes: FXX (1)
- Predicates its devices cite: 1 (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)

## Firms that cite its devices most
- Shanghai Hua EN Industrial Co, Ltd.: 1 (https://510kreport.com/company/shanghai-hua-en-industrial)

## Its most-cited devices
- K212471: Medical Face Mask (2021), cited by 1

## Recent decisions
- K212471: Medical Face Mask (Nov 4, 2021)

Source page: https://510kreport.com/company/haian-medigauze