Class Class U
PHMB Wound Dressing (K221532)
Description
PHMB Wound Dressing by Winner Medical Co., Ltd., an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK221532
Clearance Date2023-01-30
Clearance TypeTraditional
Product CodeFRO
FDA Database
View on FDA DatabasePredicate lineage for K221532
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. PHMB Wound Dressing (K221532) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192463 | PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesiv... | Winner Medical Co., Ltd. | 2020 |
| K121522 | POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) | Polyremedy, Inc. | 2012 |
Trace the full predicate network for K221532
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.