Class Class II
Surgical Face Mask (K221352)
Description
Surgical Face Mask by Wuhan Huashida Protective Products Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221352
Clearance Date2023-03-13
Clearance TypeTraditional
Product CodeFXX
Regulation Number878.4040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221352
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. Surgical Face Mask (K221352) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202903 | Surgical Face Mask | Rizhao Sanqi Medical & Health Artic... | 2022 |
Trace the full predicate network for K221352
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.