Cleared Traditional

Surgical Face Mask (Tie on/ Ear loops) (K240916) - FDA 510(k) Clearance

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

K240916 · Xiantao Daoqi Plastic Co., Ltd. · General Hospital
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Oct 2024
Decision
198d
Days
Class 2
Risk

K240916 is an FDA 510(k) clearance for the Surgical Face Mask (Tie on/ Ear loops). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Xiantao Daoqi Plastic Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on October 18, 2024 after a review of 198 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 Xiantao Daoqi Plastic Co., Ltd. devices

Submission Details

510(k) Number K240916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2024
Decision Date October 18, 2024
Days to Decision 198 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
69d slower than avg
Panel avg: 129d · This submission: 198d
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 K240916.
Procedure mask/Surgical mask/Face mask
K250082 · Winner Medical Co., Ltd. · Jun 2025
Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)
K243010 · Owens & Minor (O&M) Halyard, Inc. · May 2025
Aurelia Surgical Mask ASTM Level-3 (2130)
K242502 · Supermax Healthcare Canada-Supermax Medical · Nov 2024
PRIMED Surgical Masks and PRIMED Procedure Masks
K240286 · Primed Medical Products, Inc. · Aug 2024
Medical surgical mask
K233723 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Jul 2024
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802)
K232824 · Owens & Minor (O&M) Halyard, Inc. · Jul 2024