# K120244: Spectrashield 9500 Surgical N95 Respirator

- Pathway: 510(k) (Traditional)
- Applicant: Nexera Medical, Inc.
- Decided: Jul 5, 2012 after 160 days
- Product code: ONT (N95 Respirator With Antimicrobial/Antiviral Agent)
- 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: 5 generations back to K970835 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090414: Spectrashield 9500 Surgical Mask, Nexera Medical, Inc. (2011) Summary page 1.

## Most influential descendants
- K150729: SpectraShield 9500 Surgical N95 Respirator (2015), 0 descendants of its own

## Indications for use
The SpectraShield 9500 Surgical N95 Respirator is a single use, disposable, surgical N95 respirator, tested for continuous use up to 8 hours, embedded with a zeolite carrier containing a silver-copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the outer layer of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions. No clinical studies have been conducted comparing the ability of an untreated surgical N95 respirator and the SpectraShield model 9500 surgical N95 respirator to protect the wearer from infection, and the antibacterial treatment cannot effect pathogens that are inhaled around the edges of the respirator. The SpectraShield 9500 Surgical N95 respirator is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K120244
Methodology: https://510kreport.com/methodology