510(k) K261028
- Device
- Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
- Applicant
- Yadu Medical (Henan) Co., Ltd.
- 510(k) number
- K261028
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-07
- Date received
- 2026-03-30
- 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
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Peilong Shi
- Address
- 66 Yangze Rd., Nanpu District, Changyuan, Xinxiang, He Nan CN 453400 453400
FDA Registration Numbers#
- 3013735189
- 3030394731
- 3030088999
- 3013557562
- 3006437555
- 3018781093
- 3006723155
- 1061124
- 9614306
- 3017398283
- 3017910185
- 1066741
- 3004122598
- 3013421458
- 3014325891
- 3005012805
- 3012494290
- 3042953920
- 3014926389
- 1527607
- 3026383899
- 3013525704
- 3012811961
- 3010014065
- 3015468759
- 1065597
- 3034226814
- 1319639
- 3006538822
- 3027977504
- 3013443304
- 3010807315
- 3031982537
- 9681151
- 3011494917
- 3016763307
- 9616088
- 1721686
- 3008729549
- 3015140351
- 3004133257
- 3012421607
- 3003495693
- 3010305275
- 3016509375
- 3021274073
- 8030607
- 3014421917
- 3004362278
- 3010419931
- 3016761372
- 1058584
- 1423395
- 3016680688
- 9616876
- 9680887
- 9680646
- 3009176340
- 3014479313
- 3017171460
- 3015967359
- 3016452400
- 3014666579
- 3007082897
- 3014315560
- 3044026004
- 2032098
- 3013298431
- 1043214
- 1423537
- 9614277
- 3034629649
- 3014409525
- 3004713352
- 3006400329
- 3004361903
- 3014314985
- 3007289408
- 2431166
- 3005748481
Source Documents#
Other 510(k) Records For Product Code FYA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260407 | Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns | Principle & Will Co., Ltd. | 2026-08-26 |
| K261949 | NYES Tuff Cuff L3 Disposable Gowns | New York Embroidery Studio | 2026-07-10 |
| 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 |