# K020474: Makrite Type N95 Respirator and Surgical Mask Model 910-N95

- Pathway: 510(k) (Traditional)
- Applicant: Makrite Industries, Inc.
- Decided: Jul 23, 2002 after 161 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 K922507 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960778: Isolair Apr Type N95, Louis M. Gerson Co., Inc. (1996) Summary page 1.

## Indications for use
The Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask is a nonfiberglass, fluid resistant single-use mask 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. This device also meets CDC Guidelines for TB Exposure Control.

Source page: https://510kreport.com/device/K020474
Methodology: https://510kreport.com/methodology