Class Class II
Medical Disposable Face Masks (K222809)
Description
Medical Disposable Face Masks by Anqing Mayfield Medical Limited, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222809
Clearance Date2023-01-03
Clearance TypeTraditional
Product CodeFXX
Regulation Number878.4040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222809
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. Medical Disposable Face Masks (K222809) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K214087 | Medical Face Mask | Hubei Medlink Healthcare Co., Ltd. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240258 | Disposable Medical Face Mask (M643BE) | Makrite Industries, Inc. | 2024 |
Trace the full predicate network for K222809
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.