# K160271: N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12

- Pathway: 510(k) (Abbreviated)
- Applicant: San-M Package Co., Ltd.
- Decided: Jul 15, 2016 after 164 days
- Product code: MSH (Respirator, 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: 2 generations back to K974068 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102092: Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular Size  Model RP Ceries, Prestige Ameritech (2010) Summary page 4.

## Most influential descendants
- K172963: Master-Frank N95 Particulate Respirator (2018), 0 descendants of its own

## Indications for use
The N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 are single-use, disposable devices, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K160271
Methodology: https://510kreport.com/methodology