Submission Details
| 510(k) Number | K233723 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 21, 2023 |
| Decision Date | July 29, 2024 |
| Days to Decision | 251 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Medical surgical mask
Jul 2024
Decision
251d
Days
Class 2
Risk
About This 510(k) Submission
K233723 is an FDA 510(k) clearance for the 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 July 29, 2024, 251 days after receiving the submission on November 21, 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
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