Cleared Traditional

Biodegradable Medical surgical mask (K231155) - FDA 510(k) Clearance

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

K231155 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · General Hospital
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Nov 2023
Decision
197d
Days
Class 2
Risk

K231155 is an FDA 510(k) clearance for the Biodegradable Medical surgical mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Guangdong Kingfa Sci. & Tech.Co., Ltd. (Qingyuan, CN). The FDA issued a Cleared decision on November 7, 2023 after a review of 197 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 Guangdong Kingfa Sci. & Tech.Co., Ltd. devices

Submission Details

510(k) Number K231155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2023
Decision Date November 07, 2023
Days to Decision 197 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
68d slower than avg
Panel avg: 129d · This submission: 197d
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 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K231155.
HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124)
K232894 · Owens & Minor (O&M) Halyard, Inc. · Jan 2024
Hygenix
K232797 · Shenzhen Hygenix Industrial Co., Ltd. · Dec 2023
Aurelia Surgical Mask ASTM Level 1
K231005 · Supermax Healthcare Canada-Supermax Medical · Dec 2023
Surgical face mask
K232359 · Kingstar Medical (Xianning) Co., Ltd. · Oct 2023
Surgical Face Masks, Model: EFMDS-L50Pn BLU
K230380 · Iris USA · Aug 2023
3 Layer Surgical Mask (134252531)
K231618 · Original Mattress Factory, Inc. · Jul 2023