← FDA Medical Device Classifications

Gowns And Other Apparel

QZT · Not classified · Unknown

Classification

FDA Product Code
QZT
Device class
Not classified
Regulation
Review panel
HO
Medical specialty
Unknown
Submission type
8
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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