Cleared Traditional

Surgical Mask (K222335) - FDA 510(k) Clearance

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

K222335 · Luoyang Sunmed Devices Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
69d
Days
Class 2
Risk

K222335 is an FDA 510(k) clearance for the Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Luoyang Sunmed Devices Co., Ltd. (Luoyang, CN). The FDA issued a Cleared decision on October 11, 2022 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Luoyang Sunmed Devices Co., Ltd. devices

Submission Details

510(k) Number K222335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2022
Decision Date October 11, 2022
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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

Shenzhen Joyantech Consulting Co., Ltd.
Grace Liu

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 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K222335.
Disposable Medical Face Mask (DF3-001)
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POSE™ Health Care Surgical Mask
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Disposable Surgical Face Mask
K212649 · Lyncmed Medical Technology (Beijing) Co., Ltd. · Oct 2022
Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
K222266 · Jingzhou Haixin Green Cross Medical Products Co., Ltd. · Sep 2022
Medical Surgical Mask
K222204 · Guangzhou Zhengkang Medical Equipment Co.,Ltd · Sep 2022
Surgical Face Mask (Non-sterile)
K221976 · Xiantao Junhui Plastic Products Co., Ltd. · Sep 2022