510(k) K213893
- Device
- Comfort Gown, Safewear Gown
- Applicant
- Xuchang Zhengde Environstar Medical Products Co., Ltd.
- 510(k) number
- K213893
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-21
- Date received
- 2021-12-14
- 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
Related Records
Applicant Contact
- Contact
- Vincent Yu
- Address
- Area B, Baihua Rd. E., S. Side Of Erji River, Industry Cluster District, Yanling County, Xuchang CN 461200 461200
FDA Registration Numbers
- 3036773433
- 3030088999
- 3002807090
- 3014925393
- 3017398283
- 3038356900
- 3008770063
- 3015895045
- 3004362278
- 3031572397
- 3018058145
- 1043644
- 3016452400
- 1061124
- 3033848619
- 3006847952
- 9681151
- 3007082897
- 3005748481
- 3016680688
- 3013580507
- 3012811961
- 2183744
- 3017300722
- 3034226814
- 9614277
- 3016711507
- 2032098
- 3020163307
- 3007007790
- 1018470
- 1030451
- 3015140351
- 1066741
- 3013502418
- 9680646
- 3027977504
- 3008352384
- 3004133257
- 3012497308
- 3005012805
- 3013429557
- 3030394731
- 2648727
- 3017467279
- 3001124136
- 3013557562
- 8022129
- 3014314985
- 3010131137
- 9614306
- 1423537
- 3003495693
- 3012595397
- 3015633688
- 3010154727
- 3010305275
- 3006425876
- 3021274073
- 3011545608
- 3032507796
- 8030678
- 3003561450
- 3005099803
- 3008959420
- 3007344957
- 3013298431
- 1423625
- 3017636737
- 1651395
- 1423395
- 3011089435
- 3009176340
- 9616876
- 3030733800
- 3006538822
- 3010014065
- 3010625818
- 3014926389
Source Documents
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 |