Disposable Isolation Gown
FDA 510(k) clearance K223467 · decided 2023-02-10
Clearance details
- K-number
- K223467
- Device name
- Disposable Isolation Gown
- Applicant
- Nanning Tecbod Biological Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-11-17
- Decision date
- 2023-02-10
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- FYC
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Naning, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.