# K061375: Respirator N95 Particulate Respirator, Model 1730

- Pathway: 510(k) (Traditional)
- Applicant: Louis M. Gerson Co., Inc.
- Decided: Nov 17, 2006 after 184 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735: named in the summary without a submission number

## Indications for use
The Gerson 1730 N95 Particulate Respirator is intended to be worn by operating room personnel during healthcare procedures to protect both the patient and healthcare professionals from the transfer of microorganisms, bodily fluids and particulate material. This device also meets CDC guidelines for TB exposure. Subject device is also a surgical mask and is single use / disposable.

Source page: https://510kreport.com/device/K061375
Methodology: https://510kreport.com/methodology