Cleared Traditional

K182766 - Cufitec Surgical Mask (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K182766 is an FDA 510(k) clearance for the Cufitec Surgical Mask. Classified as Surgical Mask With Antimicrobial/antiviral Agent (product code OUK), Class II - Special Controls.

Submitted by Nbc Meshtec, Inc. (Hino, JP). The FDA issued a Cleared decision on January 3, 2019 after a review of 97 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K182766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 169d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OUK Surgical Mask With Antimicrobial/antiviral Agent
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.