Cleared Traditional

Cufitec Surgical Mask

K182766 · Nbc Meshtec, Inc. · General Hospital
Jan 2019
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K182766 is an FDA 510(k) clearance for the Cufitec Surgical Mask, a Surgical Mask With Antimicrobial/antiviral Agent (Class II — Special Controls, product code OUK), submitted by Nbc Meshtec, Inc. (Hino, JP). The FDA issued a Cleared decision on January 3, 2019, 97 days after receiving the submission on September 28, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K182766 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2018
Decision Date January 03, 2019
Days to Decision 97 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code OUK — Surgical Mask With Antimicrobial/antiviral Agent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040
Definition 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.