FDA product code · Radiology

Radiographic Protective Glove

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

IWPClass I21 CFR 892.6500510(k) exempt5 decisions since 19850 recalls

FDA lists IWP as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 892.9 applies, such as a new intended use or a different fundamental technology. 5 FDA decisions since 1985. No recall names this code.

A protective radiographic glove is a "personnel protective shield." The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Note: These devices are not patient examination gloves or surgeon's gloves. -

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, radiology panel

Twenty years of IWP 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.

FDA decisions per year · IWP

FDA has decided no IWP device since 2007.

Median 510(k) review, days · IWP

Too few IWP 510(k)s in any year since 2007 to give a median.

Recalls per year · IWP

No recall names IWP since 2007.

Adverse event reports per year · IWP

1in 2021

2007high 3 (2018) · low 0 (2007)2025

MAUDE reports naming product code IWP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	3
2019	—	1
2020	—	0
2021	—	1
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in IWP? 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 892.6500.

EAK Screen, Leaded, Operator Radiation Protector IWW Shield, Vial EAJ Apron, Leaded IWS Shield, Eye, Radiological IWT Shield, Gonadal IWQ Curtain, Protective, Radiographic IWO Apron, Protective IWX Barrier, Control Panel, X-Ray, Movable KPY Shield, Protective, Personnel IWR Holder, Syringe, Lead

Radiographic Protective Glove

What has FDA decided in IWP lately?

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