Class Class II
Disposable Medical Mask (K222545)
Description
Disposable Medical Mask by Guangzhou Fuzelong Hygiene Material Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222545
Clearance Date2023-05-19
Clearance TypeTraditional
Product CodeFXX
Regulation Number878.4040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222545
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Disposable Medical Mask (K222545) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211454 | Surgical mask | Jiangsu Xingtong Biotechnology Grou... | 2021 |
Trace the full predicate network for K222545
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.