# K212293: Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangmen Ningrui Medical Supplies Co., Ltd.
- Decided: Oct 25, 2021 after 95 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: 7 generations back to K874608 (1987). 9 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202491: Disposable Surgical Face Mask, Jiangsu Newvalue Medical Products Co., Ltd. (2021) Summary page 6.

## Most influential descendants
- K222204: Medical Surgical Mask (2022), 0 descendants of its own
- K221173: Surgical Mask (Model: 0868F, 0866F) (2022), 0 descendants of its own
- K220187: Medical Surgical Mask (Model: JM92, JM92B) (2022), 0 descendants of its own

## Indications for use
The Surgical Mask (Model:WK1701-02A, WK1701-03A and WK 1701-04A) is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile. The Model WK1701-02A is Level 1 barrier as ASTM F2100 requirements. The Model WK1701-03A is Level 2 barrier as ASTM F2100 requirements. The Model WK1701-04A is Level 3 barrier as ASTM F2100 requirements.

Source page: https://510kreport.com/device/K212293
Methodology: https://510kreport.com/methodology