# K201691: Single-Use Surgical Mask With Ear Loop

- Pathway: 510(k) (Traditional)
- Applicant: Qiqihar Hengxin Medical Supplies, Ltd.
- Decided: Sep 17, 2020 after 87 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: 8 generations back to K874608 (1987). 10 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153496: Disposable Surgical Face Mask, Xiantao Rayxin Medical Products Co., Ltd. (2016) Summary page 5.

## Most influential descendants
- K220637: 3 Ply Medical Grade Single Use Procedural Disposable Face Mask (2022), 0 descendants of its own
- K210102: Topwide Surgical Face Mask (2021), 0 descendants of its own
- K203455: Disposable Medical Mask (2021), 0 descendants of its own

## Indications for use
The Single-Use Surgical Mask with Ear Loop is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop 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. Model: M and L, blue color, and Level 2 barrier level as ASTM F2100.

Source page: https://510kreport.com/device/K201691
Methodology: https://510kreport.com/methodology