510(k) K233183
- Device
- Surgical Gown (40083)
- Applicant
- Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.
- 510(k) number
- K233183
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-02-01
- Date received
- 2023-09-28
- 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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Melody Wang
- Address
- Southern Industrial Zone (Xinlirenkou) Xiantao CN 433011 433011
FDA Registration Numbers
- 3036773433
- 3030088999
- 3002807090
- 3014925393
- 3017398283
- 3038356900
- 3008770063
- 3015895045
- 3004362278
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- 3007156625
- 3010873451
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- 3029897710
- 3005246893
- 3034629649
- 3006400329
- 8043817
- 3016761372
- 1526350
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- 1123137
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- 3004111573
- 3008252907
- 3031982537
- 3013548473
- 3006113262
- 3000268902
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- 3008837339
- 3013600605
- 3030419987
- 3005142514
- 3014421917
- 3010419931
- 3005675811
- 3008502431
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- 1054241
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- 3016844398
- 3026536498
- 1818910
- 9680794
- 3015960676
- 3014479313
- 3016678045
- 3004713352
- 3002806603
- 3043226252
- 1527185
- 8030607
- 3014159736
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- 3025771437
- 9680357
- 3013421458
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- 3008824097
- 3005997949
- 3011547453
- 9680222
- 3008559312
- 9616096
- 3014213264
- 3009114792
- 3005391805
- 3034204758
- 3011497662
- 3023228837
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code FYA
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|---|---|---|---|
| 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 |
| K230707 | Skypro, Surgical Gown 6021 | Skypro Medical Supplies Company | 2023-10-12 |
| K230610 | Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) | Dongguan Shin YI Healthcare Products Factory | 2023-08-23 |