Class Class II
Surgical Gown (K213844)
Description
Surgical Gown by Bayteks Teknik Tekstil San. VE Tic. A.S., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213844
Clearance Date2023-02-16
Clearance TypeTraditional
Product CodeFYA
Regulation Number878.4040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213844
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 Gown (K213844) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202706 | Surgical Gown (Sterile), Surgical Gown (Non-sterile) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT ... | 2020 |
| K190950 | Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Med... | Medline Industries, Inc. | 2019 |
Trace the full predicate network for K213844
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.