# K212273: Cross Protection ResQ300 Plus Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Cross Protection (M) Sdn Bhd
- Decided: Aug 17, 2022 after 393 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: 5 generations back to K874608 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051291: Non-Sterile Surgical Mask, A.R. Medicom, Inc. (2005) Summary page 4.

## Indications for use
The Cross Protection ResQ300 Plus Surgical Face Masks are intended to be used as isolation face mask, procedure mask and dental face mask. Cross Protection ResQ300 Plus Surgical Face Masks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, bodily fluids and particulate material.

Source page: https://510kreport.com/device/K212273
Methodology: https://510kreport.com/methodology