Class Class II
High Protection Surgical Gown (K222456)
Description
High Protection Surgical Gown by 3A Medical Products Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222456
Clearance Date2023-03-12
Clearance TypeTraditional
Product CodeFYA
Regulation Number878.4040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222456
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. High Protection Surgical Gown (K222456) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221819 | 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgic... | Winner Medical Co., Ltd. | 2022 |
| K212869 | Disposable Surgical Gown, Disposable Reinforced Surgical Gown | Fugou County Shenxiang Manufacturin... | 2021 |
Trace the full predicate network for K222456
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.