Class Class II
Ideal Med Pro 3-Ply Disposable Face Mask (K221682)
Description
Ideal Med Pro 3-Ply Disposable Face Mask by Jsn Holdings, LLC, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221682
Clearance Date2023-01-13
Clearance TypeTraditional
Product CodeFXX
Regulation Number878.4040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221682
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. Ideal Med Pro 3-Ply Disposable Face Mask (K221682) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200847 | Surgical Face Mask | Mexpo International, Inc. | 2020 |
| K060776 | SURGICAL FACE MASK | Hong YA Non-Woven Products Co., Ltd. | 2006 |
Trace the full predicate network for K221682
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.