# K211487: MAF Guard

- Pathway: 510(k) (Abbreviated)
- Applicant: Maf Clothing Pvt Ltd Unit-3
- Decided: Dec 8, 2021 after 209 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 K970835 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173062: Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)), V&Q Manufacturing Corporation (2018) Summary page 4.

## Indications for use
MAF Guard is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

Source page: https://510kreport.com/device/K211487
Methodology: https://510kreport.com/methodology