Cleared Traditional

Dukal Corporation Level 2 Surgical Mask with Ear Loops (K201421) - FDA 510(k) Clearance

Also marketed or referenced as:
Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons

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

K201421 · Dukal Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
252d
Days
Class 2
Risk

K201421 is an FDA 510(k) clearance for the Dukal Corporation Level 2 Surgical Mask with Ear Loops. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Dukal Corporation (Ronkonkoma, US). The FDA issued a Cleared decision on February 5, 2021 after a review of 252 days - an extended review cycle.

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.

View all Dukal Corporation devices

Submission Details

510(k) Number K201421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2020
Decision Date February 05, 2021
Days to Decision 252 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 129d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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.

Regulatory Peers - FXX Mask, Surgical

All 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K201421.
Disposable Surgical Mask
K202341 · Shanghai Jianzhong Medical Packaging Co., Ltd. · Feb 2021
Standard Procedure Mask, Standard Surgical Mask
K202605 · Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · Feb 2021
nPro Surgical Mask
K203265 · Np Medical, Inc. · Feb 2021
Freudenberg Surgical Mask
K210063 · Freudenberg Performance Materials LP · Feb 2021
Medical Face Mask
K202493 · Gemtier Medical (Shanghai), Inc. · Feb 2021
Medical Face Masks
K202627 · Guilin Hbm Sanitary Protections, Inc. · Feb 2021