510(k) K101128
K101128 is an FDA 510(k) premarket notification submitted by Filligent Limited for the device "BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013". The FDA issued a decision of Substantially Equivalent on May 26, 2011. The device falls under product code OUK (Surgical Mask With Antimicrobial/Antiviral Agent), a Class II device regulated under 21 CFR 878.4040. Filligent Limited has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2011
- Date Received
- April 22, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Surgical Mask With Antimicrobial/Antiviral Agent
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type
A single use, disposable surgical mask for occupational use to cover the nose and mouth of the wearer to protect from the transfer of microorganisms,body fluids and particulates and has an added antimicrobial and/or antiviral agent which kills specific pathogens under specified contact conditions.