510(k) K211422
- Device
- Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown
- Applicant
- Jiangsu Medplus Non-woven Manufacturer Co., Ltd.
- 510(k) number
- K211422
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-07-02
- Date received
- 2021-05-07
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Shuying An
- Address
- #217 E. Wencheng Rd., Economic Development Zone Siyang CN 223700 223700
FDA Registration Numbers#
- 1721686
- 3005246893
- 3010041511
- 3010419931
- 3013548473
- 3033536319
- 1527607
- 3004911384
- 3023228837
- 1319639
- 3005748481
- 3004513970
- 3021274073
- 3011545608
- 3026536498
- 3012811961
- 3044026004
- 3006425876
- 1423625
- 1123137
- 9616876
- 1928237
- 3015967359
- 3008770063
- 3033848619
- 1921846
- 3014314985
- 3003495693
- 3014325891
- 3010873451
- 3001650535
- 3005595283
- 3010610950
- 3016678045
- 3042245424
- 3032507796
- 1423537
- 3016761372
- 3030419987
- 3016509375
- 3000268902
- 3011089435
- 3017171460
- 3013410562
- 3036773433
- 3031572397
- 3044906632
- 3005142514
- 3008352384
- 3002807090
- 3012595397
- 9680646
- 3015633688
- 3004133257
- 3017195371
- 3014479313
- 9680794
- 3005675811
- 3013466775
- 3008729549
- 3016680688
- 3004362278
- 3015895045
- 3006723155
- 8030607
- 8022129
- 1643817
- 3016705853
- 3004713352
- 3007344957
- 3015960676
- 3002806603
- 3005997949
- 3030733800
- 1058584
- 3016452400
- 3030088999
- 8030672
- 3013421458
- 3003561450
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 |
| K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | 2026-08-07 |
| 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 |
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