Cleared Traditional

Surgical Face Mask (Non-sterile) (K221976) - FDA 510(k) Clearance

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

K221976 · Xiantao Junhui Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
77d
Days
Class 2
Risk

K221976 is an FDA 510(k) clearance for the Surgical Face Mask (Non-sterile). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Xiantao Junhui Plastic Products Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on September 20, 2022 after a review of 77 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 Xiantao Junhui Plastic Products Co., Ltd. devices

Submission Details

510(k) Number K221976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2022
Decision Date September 20, 2022
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
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

Shanghai Sungo Management Consulting Company Limited.
Ivy Wang

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 K221976.
Surgical Mask
K222335 · Luoyang Sunmed Devices Co., Ltd. · Oct 2022
Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
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Medical Surgical Mask
K222204 · Guangzhou Zhengkang Medical Equipment Co.,Ltd · Sep 2022
AllureTM Surgical Mask
K212926 · Allure Gift Wraps Private Limited · Sep 2022
Surgical Face Masks (Ear Loops And Tie-On)
K221534 · San-M Package Co., Ltd. · Sep 2022
LAITEST Medical Face Mask
K214035 · R&R Medical Corporation, Ltd. · Sep 2022