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#
- 1417592
- 8043817
- 3004361903
- 3013548473
- 3014409525
- 3005675811
- 3013659050
- 3012344767
- 3042953920
- 2431166
- 3016844398
- 3005997949
- 3010041511
- 3004111573
- 3019798849
- 3011494917
- 1423395
- 3004122598
- 3004513970
- 1055892
- 3008959420
- 3030733800
- 3007344957
- 3016680688
- 3021274073
- 3006891803
- 3031572397
- 3015068387
- 1643817
- 3012497308
- 3005246893
- 1527607
- 3003348807
- 1836161
- 3005012805
- 3008191254
- 3010625818
- 3013466775
- 3006973666
- 1043644
- 3031982537
- 2032098
- 3011547453
- 3016452400
- 3030088999
- 3043226252
- 3007289408
- 3030446844
- 9680357
- 3014325891
- 3016509375
- 1123137
- 3004713352
- 3015633688
- 3032507796
- 8030607
- 9680794
- 3001650535
- 3014479313
- 3016763307
- 8022129
- 3006538822
- 3018058145
- 3015960676
- 3009750712
- 9616088
- 3009443860
- 3005391805
- 3010305275
- 3006113262
- 3007007790
- 3013502418
- 3003561450
- 3014213264
- 3038356900
- 3013410562
- 3014315560
- 3010807315
- 3042245424
- 1061124
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 |