Class Class II
Procedure mask/Surgical mask/Face mask (K250082)
Description
Procedure mask/Surgical mask/Face mask by Winner Medical Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250082
Clearance Date2025-06-18
Clearance TypeTraditional
Product CodeFXX
Regulation Number878.4040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250082
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. Procedure mask/Surgical mask/Face mask (K250082) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223232 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | 2023 |
| K220194 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | 2022 |
Trace the full predicate network for K250082
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.