Cleared Traditional

Sparta 3-Ply Surgical Disposable Face Mask (K220378) - FDA 510(k) Clearance

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

K220378 · Sparta East, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
140d
Days
Class 2
Risk

K220378 is an FDA 510(k) clearance for the Sparta 3-Ply Surgical Disposable Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Sparta East, LLC (Medley, US). The FDA issued a Cleared decision on June 30, 2022 after a review of 140 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.

View all Sparta East, LLC devices

Submission Details

510(k) Number K220378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2022
Decision Date June 30, 2022
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
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 Consultant

Thomas Regulatory Resolutions, Inc.
Dallas L. Thomas

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FXX Mask, Surgical

All 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K220378.
Disposable Medical Face Mask (ear loop)
K221196 · Xiantao Topmed Nonwoven Protective Products Co., Ltd. · Jul 2022
Surgical face mask
K220777 · Hubei Qianjiang Kingphar Medical Material Co., Ltd. · Jul 2022
Surgical Mask (Model: 0868F, 0866F)
K221173 · Jiangxi Sanhao Medical Instruments Co.,Ltd · Jul 2022
Magnum
K220670 · Magnum Health and Safety Pvt, Ltd. · Jun 2022
Medical Face Mask
K221272 · Shandong Xingyu Gloves Co., Ltd. · Jun 2022
Medical Face Mask (M001)
K221273 · Xingyu Medical Tech Co., Ltd. · Jun 2022