# K141875: Pasture 60S Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Pasture Pharma Pte, Ltd.
- Decided: May 5, 2015 after 298 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). 9 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092580: Tidi Facemask, Tidi Products,Llc (2010) Summary page 5.

## Most influential descendants
- K152197: Skypro, SP01 Mask (2016), 2 descendants of its own
- K202255: Skypro, SP02 Mask (3) (2021), 0 descendants of its own
- K203646: Disposable Medical Face Mask (2021), 0 descendants of its own

## Indications for use
Pasture 60S Surgical Mask is a surgical mask that is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K141875
Methodology: https://510kreport.com/methodology