# K232968: Grande Medical Masks, Model SF-600

- Pathway: 510(k) (Traditional)
- Applicant: Golden Grande Corp.
- Decided: Jun 6, 2024 after 259 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 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)
- K160269: Surgical Face Masks (Ear loops and Tie-on), San-M Package Co., Ltd. (2016) Summary page 5.

## Indications for use
Grande Medical Masks is intended to be worn to protect both the patient and healthcare personnel from the 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. The Grande Medical Masks are single use, disposable device, provided non-sterile.

Source page: https://510kreport.com/device/K232968
Methodology: https://510kreport.com/methodology