Submission Details
| 510(k) Number | K231155 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Biodegradable Medical surgical mask
Nov 2023
Decision
197d
Days
Class 2
Risk
About This 510(k) Submission
K231155 is an FDA 510(k) clearance for the Biodegradable Medical surgical mask, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Guangdong Kingfa Sci. & Tech.Co., Ltd. (Qingyuan, CN). The FDA issued a Cleared decision on November 7, 2023, 197 days after receiving the submission on April 24, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.
Device Classification
| Product Code | FXX — Mask, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4040 |
Manufacturer
Similar Devices — FXX Mask, Surgical
All 605
K252534 · Zhejiang Hangkang Medical Equipment Co., Ltd.
· Mar 2026
K253398 · Efofex, Inc.
· Feb 2026
K252830 · Beatles Medical Supplies (Xiantao) Co., Ltd.
· Jan 2026
K252650 · Makrite Industries, Inc.
· Jan 2026
K243342 · Kp Trading Co., Ltd.
· Dec 2025
K252941 · O&M Halyard, Inc.
· Dec 2025
More from Guangdong Kingfa Sci. &...
View all
K233723
· FXX · Jul 2024
K221983
· LZA · Apr 2023
K230046
· LYZ · Mar 2023
K222612
· LYY · Nov 2022
K222714
· LZA · Oct 2022