# K212368: Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Tiankang Medical Technology Co., Ltd.
- Decided: Oct 24, 2021 after 86 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: 4 generations back to K874608 (1987). 6 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110455: Kimberly-Clark Low Barrier, Astm 2100 Face Masks, Kimberly-Clark Corp. (2011) Summary page 4.

## Most influential descendants
- K220670: Magnum (2022), 1 descendant of its own
- K251902: Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) (2025), 0 descendants of its own
- K222483: Surgical Face Mask (2023), 0 descendants of its own
- K222529: Surgical Face Mask (2022), 0 descendants of its own

## 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(s), provided non-sterile.

Source page: https://510kreport.com/device/K212368
Methodology: https://510kreport.com/methodology