510(k) K211765
- Device
- Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown
- Applicant
- Cardinal Health, LLC
- 510(k) number
- K211765
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-23
- Date received
- 2021-06-08
- Regulation
- 878.4040
- Classification name
- Gown, Surgical
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Brenda Gerena
- Address
- 3651 Birchwood Dr. Waukegan IL US 60085 60085
FDA Registration Numbers#
- 3029897710
- 3015173212
- 1423537
- 9680887
- 3010796396
- 3006425876
- 3013410562
- 3006538822
- 9681151
- 3016844398
- 3034669683
- 3004713352
- 3008729549
- 1526350
- 3012268821
- 1651395
- 3007289408
- 3031572397
- 3005391805
- 3034629649
- 3017398283
- 3036773433
- 3017300722
- 1423395
- 2431166
- 3018058145
- 3006540014
- 3006113262
- 3008770063
- 3009443860
- 9680357
- 3007088677
- 3023228837
- 3003495693
- 3005997949
- 3030067857
- 9616088
- 3015895045
- 3019798849
- 3042245424
- 3012497308
- 1319639
- 3008252907
- 3014666579
- 3033848619
- 3001650535
- 1054241
- 3014315560
- 1928237
- 1065597
- 3016452400
- 3012595397
- 3002807090
- 3012811961
- 3030088999
- 1423625
- 3013502418
- 1018470
- 3014314985
- 9614306
- 3017636737
- 3011494917
- 3015633688
- 3016705853
- 3000268902
- 3016763307
- 1721686
- 3005142514
- 1818910
- 3014479313
- 2029015
- 3013421458
- 1921846
- 3013429557
- 3013496867
- 1123137
- 3038718579
- 1055236
- 3011554160
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FYA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K230707 | Skypro, Surgical Gown 6021 | Skypro Medical Supplies Company | 2023-10-12 |