# K133070: SURGICAL FACE MASK (Ear Loops and Tie-on)

- Pathway: 510(k) (Traditional)
- Applicant: Bh Medical Products Co., Ltd.
- Decided: Jun 22, 2015 after 630 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.
170 later devices descend from it; 9 cite it directly.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131879: KC 300 Surgical Mask, Kimberly-Clark Corp. (2013). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K153496: Disposable Surgical Face Mask (2016), 158 descendants of its own
- K182515: Surgical Face Mask (2019), 50 descendants of its own
- K182514: Surgical Face Mask (2019), 29 descendants of its own
- K200923: Single-use Surgical Mask (2020), 16 descendants of its own
- K203426: Surgical Face Mask (non-sterile) (2021), 13 descendants of its own

## Indications for use
The surgical face masks 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 is a single use, disposable device(s), provided non-sterile.

Source page: https://510kreport.com/device/K133070
Methodology: https://510kreport.com/methodology