K242689
- 510(k) number
- K242689
- Device name
- AAMI Level 4 Protective; Gown
- Applicant
- Azac Group CA · US
- Product code
- QPC — Gown, Non-Sterile, Non-Isolation, Intended To Provid
- Decision date
- 2025-01-13
- Date received
- 2024-09-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K242689
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.