Class Class II
Disposable 4 Layers Surgical Face Mask (K230093)
Description
Disposable 4 Layers Surgical Face Mask by Social Medical Supply, LLC, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230093
Clearance Date2023-03-02
Clearance TypeTraditional
Product CodeFXX
Regulation Number878.4040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230093
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 4 Layers Surgical Face Mask (K230093) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221272 | Medical Face Mask | Shandong Xingyu Gloves Co., Ltd. | 2022 |
Trace the full predicate network for K230093
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.