FDA product code · General Hospital · Class 2
QPC: Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
QPC is FDA's product code for "Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection": a Class 2 device classified under 21 CFR 878.4040, reviewed by the General Hospital panel.
510(k) review time for QPC
Across 11 510(k) clearances under QPC decided from 2018-01-01 to 2026-10-06, the median was 178 days from FDA receipt to decision. Half took between 127 and 272 days, and 80% were decided within 308 days. These are past clearances, not a forecast for a new submission.
| Fastest | 88 |
|---|---|
| 25th percentile | 127 |
| Median | 178 |
| 75th percentile | 272 |
| 80th percentile | 308 |
| 90th percentile | 353 |
| Slowest | 386 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
FDA-recognized standards that cite QPC
3 FDA recognized consensus standards cite QPC, 2 of them recognized only in part, among them ANSI AAMI PB70:2022; ASTM F1671/F1671M-22; ASTM F739-20. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 6-487 ANSI AAMI PB70:2022 (partial recognition) — Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
- 6-488 ASTM F1671/F1671M-22 — Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
- 6-496 ASTM F739-20 (partial recognition) — Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.