# K102092: Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular Size  Model RP Ceries

- Pathway: 510(k) (Abbreviated)
- Applicant: Prestige Ameritech
- Decided: Oct 6, 2010 after 71 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: 1 generation back to K974068 (1997). 1 ancestor in all.
2 later devices descend 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)
- K974068: PFR95 Particulate Filter Respirator and Surgical Mask Regular Size, PFR95 Particulate Filter Respirator and Surgical, Tecnol Medical Products, Inc. (1997) Summary page 2.

## Most influential descendants
- K160271: N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 (2016), 1 descendant of its own
- K172963: Master-Frank N95 Particulate Respirator (2018), 0 descendants of its own

## Indications for use
The Prestige Ameritech N95 Respirator and Surgical Mask RP8802O is a single use non-sterile disposable device intended to be-worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K102092
Methodology: https://510kreport.com/methodology