510(k) K233068
- Device
- Disposable Surgical Gown
- Applicant
- Nanning Tecbod Biological Technology Co., Ltd.
- 510(k) number
- K233068
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-03-29
- Date received
- 2023-09-26
- 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
- Statement
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Bing Yao Chen
- Address
- Rm. 601 Fool 6, B2 Bldg., # 19 Guokai Dadao, Nanning, Guangxi, People'S Republic Nanning CN 530033 530033
FDA Registration Numbers
- 3036773433
- 3030088999
- 3002807090
- 3014925393
- 3017398283
- 3038356900
- 3008770063
- 3015895045
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
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| K241214 | ProPel SG3 Surgical Gown | Standard Textile Co., Inc. | 2024-09-10 |
| K233571 | GCI Surgical Gown | George Courey, Inc. | 2024-08-02 |
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| 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 |