← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4040
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K252940PolyConversions, Inc. · 510k2025-12-16
K242689Azac Group · 510k2025-01-13

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →