# K153496: Disposable Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Xiantao Rayxin Medical Products Co., Ltd.
- Decided: Jun 15, 2016 after 191 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.
158 later devices descend from it; 40 cite it directly.
0 of 168 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133070: SURGICAL FACE MASK (Ear Loops and Tie-on), Bh Medical Products Co., Ltd. (2015) Summary page 5.

## Most influential descendants
- K182515: Surgical Face Mask (2019), 50 descendants of its own
- K182514: Surgical Face Mask (2019), 29 descendants of its own
- K200923: Single-use Surgical Mask (2020), 16 descendants of its own
- K203426: Surgical Face Mask (non-sterile) (2021), 13 descendants of its own
- K211827: Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) (2021), 6 descendants of its own

## Indications for use
The Disposable 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/K153496
Methodology: https://510kreport.com/methodology