# K211827: Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Lanhine Medical Products, Ltd.
- Decided: Sep 23, 2021 after 101 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: 9 generations back to K874608 (1987). 11 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200923: Single-use Surgical Mask, Byd Precision Manufacturer Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K213806: Disposable Medical Face Mask (2022), 2 descendants of its own
- K213601: Surgical Mask (2022), 0 descendants of its own
- K223055: Disposable Medical Face Mask (2022), 0 descendants of its own
- K222697: Disposable Medical Face Mask  (DF3-001) (2022), 0 descendants of its own
- K221976: Surgical Face Mask (Non-sterile) (2022), 0 descendants of its own

## Indications for use
The Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) 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 a single use, disposable device(s), provided non-sterile.

Source page: https://510kreport.com/device/K211827
Methodology: https://510kreport.com/methodology