# K212610: Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Nanhai Plus Medical Co, Ltd.
- Decided: Jan 26, 2022 after 162 days
- Product code: FXX (Mask, 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: 6 generations back to K874608 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160269: Surgical Face Masks (Ear loops and Tie-on), San-M Package Co., Ltd. (2016) Summary page 4.

## Indications for use
The Surgical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile. Level 2 Surgical Face Mask Models: Tie strap type: 522-001, 522-003, 522-005 Ear loop type: 522-002, 522-004, 522-006 Level 3 Surgical Face Mask Models: Tie strap type: 533-001, 533-003, 533-005 Ear loop type: 533-002, 533-004, 533-006

Source page: https://510kreport.com/device/K212610
Methodology: https://510kreport.com/methodology