# K160269: Surgical Face Masks (Ear loops and Tie-on)

- Pathway: 510(k) (Abbreviated)
- Applicant: San-M Package Co., Ltd.
- Decided: Sep 6, 2016 after 217 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). 7 ancestors in all.
60 later devices descend from it; 39 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110455: Kimberly-Clark Low Barrier, Astm 2100 Face Masks, Kimberly-Clark Corp. (2011) Summary page 4.
- K111402: KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300, Procedure Mask, Fluidshield Model, Kimberly-Clark (2011) Summary page 4.

## Most influential descendants
- K202491: Disposable Surgical Face Mask (2021), 4 descendants of its own
- K212293: Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) (2021), 3 descendants of its own
- K211462: Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask (2021), 3 descendants of its own
- K202424: Surgical Mask-Models CR02-2, CR02 (2021), 3 descendants of its own
- K220194: Procedure mask/Surgical mask/Face mask (2022), 2 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, provided non-sterile. Level 1 Face Mask Models: # EL 10000, EL 10010, TO 10000, TO 10010 Level 2 Face Mask Models: # EL 20000, EL 20010, TO 20000, TO 20010 Level 3 Face Mask Models: # EL 30000, EL 30010, TO 30000, TO 30010

Source page: https://510kreport.com/device/K160269
Methodology: https://510kreport.com/methodology