# K050193: Gerson 2130/31 Type N95 Niosh Certified Surgical Respirator

- Pathway: 510(k) (Traditional)
- Applicant: Louis M. Gerson Co., Inc.
- Decided: Apr 11, 2005 after 74 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063334: Shanghai Ganghai Model Giko 1400 (2006), 0 descendants of its own

## Indications for use
The Gerson Model 2130/2131 Disposable Surgical N95 Particulate Respirators are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material. The respirator is a single-use disposable. The 2130 and 2131 Model respirators are available in either blue or white colors. This device also meets CDC Guidelines for TB Exposure Control.

Source page: https://510kreport.com/device/K050193
Methodology: https://510kreport.com/methodology