# K202137: Disposable medical mask

- Pathway: 510(k) (Traditional)
- Applicant: U-Play Products Corporation
- Decided: Mar 4, 2021 after 216 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.
1 later device descends from it; 1 cites it directly.
0 of 8 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
- K220377: Procedure Mask (2022), 0 descendants of its own

## Indications for use
Disposable Medical 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/K202137
Methodology: https://510kreport.com/methodology