510(k) K200824
- Device
- Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown
- Applicant
- Cardinal Health 200, LLC
- 510(k) number
- K200824
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-07-29
- Date received
- 2020-03-30
- Regulation
- 878.4040
- Classification name
- Gown, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Caroline Miceli
- Address
- 3651 Birchwood Dr. Waukegan IL US 60085 60085
FDA Registration Numbers#
- 3010131137
- 3012421607
- 3011089435
- 3005142514
- 9616088
- 1061124
- 3007088677
- 3017884933
- 3010610950
- 3006437555
- 8043817
- 1818910
- 3002806603
- 3015068387
- 3013496867
- 3011497662
- 3004361903
- 3011554160
- 3026536498
- 3032507796
- 3009114792
- 3030394731
- 3011547453
- 3006425876
- 8030678
- 3010419931
- 3016678045
- 3006891803
- 1211998
- 3001650535
- 3008824097
- 3010154727
- 3008328679
- 3010014065
- 3010621964
- 3015058854
- 3014925393
- 1123137
- 3001124136
- 2648727
- 3012497308
- 3016705853
- 3038718579
- 3006400329
- 3014314985
- 1651395
- 1066741
- 3010807315
- 3034669683
- 3011494917
- 3013298431
- 3015895045
- 9614306
- 9680887
- 9614277
- 3027977504
- 3019798849
- 3013960812
- 3013502418
- 3015140351
- 3008252907
- 3031572397
- 3021274073
- 3034629649
- 3030733800
- 3044026004
- 1417592
- 9616876
- 3004122598
- 9681151
- 3014315560
- 3007007790
- 3014479313
- 1526350
- 3013735189
- 3014926389
- 3000268902
- 3010305275
- 3003495693
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FYA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252575 | Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) | New York Embroidery Studio (NYES) | 2026-06-04 |
| K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | Hindernis DE Mexico, S.A.P.I. DE C.V. | 2026-05-12 |
| K253243 | Cardinal Health™ Poly Reinforced Surgical Gown | Cardinal Health 200, LLC | 2026-04-28 |
| K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) | Hubei Xinxin Non-Woven Co., Ltd. | 2026-04-20 |
| K251860 | Copioumed AAMI 3 Surgical Gown | Copioumed International, Inc. | 2026-02-26 |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced) | Yadu Medical (Henan) Co., Ltd. | 2026-02-04 |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | 2025-12-03 |
| K243522 | ViVi® Toga Premium | Thi Total Healthcare Innovation GmbH | 2025-05-30 |
| K242937 | Dream Medi Sterile Surgical Gown (SurgicalGownUL) | Dae Myung Chemical Co., Ltd. (Vietnam) | 2025-05-05 |
| K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves | Medline Industries, LP | 2025-02-26 |
| K241272 | Stryker Steri-Shield 8 Surgical Hoods and Togas | Stryker Instruments | 2024-10-16 |
| K241214 | ProPel SG3™ Surgical Gown | Standard Textile Co., Inc. | 2024-09-10 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases