FDA Product Code QPC: Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection
A Non-sterile, Non-isolation Gown Intended To Be Worn By Healthcare Personnel To Provide Moderate Or High Barrier Protection In Non-sterile And Non Patient Isolation Situations. Gowns With Antimicrobial/antiviral Agents Or Claims Are Excluded.
Leading manufacturers include Medline Industries, LP, Azac Group and PolyConversions, Inc..
FDA 510(k) Cleared Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection Devices (Product Code QPC)
About Product Code QPC - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code QPC since 2017, with 10 receiving FDA clearance (average review time: 253 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under QPC have taken an average of 111 days to reach a decision - down from 288 days historically, suggesting improved FDA processing for this classification.
QPC devices are reviewed by the General Hospital panel. Browse all General Hospital devices →