510(k) K090414
K090414 is an FDA 510(k) premarket notification submitted by Nexera Medical, Inc. for the device "SPECTRASHIELD 9500 SURGICAL MASK". The FDA issued a decision of Substantially Equivalent on February 24, 2011. The device falls under product code ONT (N95 Respirator With Antimicrobial/Antiviral Agent), a Class II device regulated under 21 CFR 878.4040. Nexera Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2011
- Date Received
- February 18, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- N95 Respirator With Antimicrobial/Antiviral Agent
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type
A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions.