QZT — Gowns And Other Apparel Class N
FDA product code QZT covers "Gowns And Other Apparel", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QZT
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Unknown
- Implant
- No
Definition
Gowns and other apparel are authorized under the EUA for use by HCPs in healthcare settings in accordance with CDC recommendations to protect both HCPs and patients from the transfer of SARS-CoV-2 in low or minimal risk level situations to prevent the spread of COVID-19.