510(k) K253243
- Device
- Cardinal Health Poly Reinforced Surgical Gown
- Applicant
- Cardinal Health 200, LLC
- 510(k) number
- K253243
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-28
- Date received
- 2025-09-29
- Regulation
- 878.4040
- Classification name
- Gown, Surgical
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Statement
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Yuan Zhou
- Address
- 3651 Birchwood Dr. Waukegan IL US 60085 60085
FDA Registration Numbers
- 3036773433
- 3030088999
- 3002807090
- 3014925393
- 3017398283
- 3038356900
- 3008770063
- 3015895045
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
Other 510(k) Records For Product Code FYA
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|---|---|---|---|
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| K233571 | GCI Surgical Gown | George Courey, Inc. | 2024-08-02 |
| K233068 | Disposable Surgical Gown | Nanning Tecbod Biological Technology Co., Ltd. | 2024-03-29 |
| K233183 | Surgical Gown (40083) | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | 2024-02-01 |
| K230707 | Skypro, Surgical Gown 6021 | Skypro Medical Supplies Company | 2023-10-12 |
| K230610 | Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) | Dongguan Shin YI Healthcare Products Factory | 2023-08-23 |