Cleared Traditional

K202843 - Surgical Face Masks (Sterile)

K202843 is an FDA 510(k) clearance for Surgical Face Masks (Sterile), manufactured by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K202843 · B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · General Hospital
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Jan 2021
Decision
109d
Days
Class 2
Risk

K202843 is an FDA 510(k) clearance for the Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. (Beijing, CN). The FDA issued a Cleared decision on January 12, 2021 after a review of 109 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 B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. devices

FDA 510(k) Submission Details - K202843

510(k) Number K202843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2020
Decision Date January 12, 2021
Days to Decision 109 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
20d faster than avg
Panel avg: 129d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

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

Mid-Link Consulting Co, Ltd.
Diana Hong

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 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K202843.
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Disposable Medical Surgical Mask
K201625 · Tianjin Saiyuan Technology Co., Ltd. · Jan 2021
Medical Surgical Mask-Model MP002-5, MP002-6
K202577 · Jiangmen Sure&Me Medical Product Co., Ltd. · Jan 2021
Disposable Surgical Face Mask
K202491 · Jiangsu Newvalue Medical Products Co., Ltd. · Jan 2021
Medical Surgical Masks-Non Sterile
K202594 · Shandong T&F Nonwoven Co., Ltd. · Jan 2021