# K150729: SpectraShield 9500 Surgical N95 Respirator

- Pathway: 510(k) (Traditional)
- Applicant: Nexera Medical, Inc.
- Decided: Dec 29, 2015 after 284 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: 6 generations back to K970835 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120244: Spectrashield 9500 Surgical N95 Respirator, Nexera Medical, Inc. (2012) Summary page 4.
- K122702: Biofriend Biomask N95 Surgical Respirator, Filligent Limited (2013) Summary page 4.

## Indications for use
The SpectraShield 9500 Surgical Mask is a single use, disposable, surgical mask, 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, and inactivates 99.99% of test influenza viruses after 5 minutes of contact with the surface of the mask. 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. In vitro tests have demonstrated 99.99% inactivation on the surface of the outer layer of the mask when tested against the following seasonal, pandemic, avian, swine and equine influenza viruses: Influenza A subtypes: H1N1 (A/California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A /Puerto Rico/8/1934), H3N2 (A/Wisconsin/67/2005, A/Brisbane/10/2007, A/Hong Kong/8/1968, A/Victoria/3/75), H2N2 ( A/2/Japan/305/1957); Avian Flu (bird flu) subtypes: Avian Influenza A (H5N1), Avian Influenza A (H9N2), Swine Flu subtype: H1N1 (A/Swine/1976/1931), Equine Flu subtypes: H3N8 (A/Equine/2/Miami/1963), Influenza B strains: B/Florida/4/2006, B/Brisbane/60/2008, B/Lee/40. No clinical studies have been conducted comparing the ability of an untreated surgical mask and the SpectraShield model 9500 surgical mask to protect the wearer from infection, and the antibacterial/anti-influenza virus treatment cannot affect pathogens that are inhaled around the edges of the respirator. The SpectraShield 9500 Surgical Mask is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K150729
Methodology: https://510kreport.com/methodology