# Foshan Nanhai Plus Medical Co, Ltd.

- Location (FDA's records): Foshan, CN
- FDA decisions: 8 (2015–2022): 8 510(k) clearances
- Product codes: FYA (5), FXX (1), FYC (1), KKX (1)
- 510(k) review time since 2016: median 187 days, against 177 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (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)

## Recent decisions
- K222480: Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) (Nov 14, 2022)
- K213177: Plus Medical Cover Gown (May 11, 2022)
- K211036: Plus Medical Chemotherapy Gown (May 4, 2022)
- K212698: Plus Medical Isolation Gown Level 3 (Mar 2, 2022)
- K212610: Surgical Face Mask (Jan 26, 2022)
- K210143: Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) (Jul 22, 2021)
- K133075: Plus Surgical Gowns (EO Sterilized), PMGB-XXX (Jun 24, 2015)
- K133080: Plus Surgical Drapes (EO Sterilized), PMDB-XXX (Jun 24, 2015)

Source page: https://510kreport.com/company/foshan-nanhai-plus-medical