FDA product code · General hospital

Antimicrobial Drapes

Name: FDA decisions, review times, recalls and adverse event reports for product code PLY
Creator: 510(k) Report

PLYClass II21 CFR 878.4370510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Used to reduce the risk of skin flora contamination of the surgical wound during a surgical procedure.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general hospital panel

Twenty years of PLY at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — PLY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PLY? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 878.4370.

HMW Drape, Microscope, Ophthalmic HMT Drape, Patient, Ophthalmic EYX Drape, Pure Latex Sheet, With Self-Retaining…EYY Drape, Urological, Disposable MMP Cover, Barrier, Protective KKX Drape, Surgical, Antimicrobial KGW Ring (Wound Protector), Drape Retention…LRO General Surgery Tray FNW Pad, Kelly PUI Drape, Surgical, Exempt ERY Drape, Surgical, Ent NZP Sealant, Microbial