FDA product code · General hospital

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

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

OPJClass I21 CFR 880.6250510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as astm d6978-05, standard practice for assessment of resistance of medical gloves to permeation by…

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 OPJ 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 · OPJ

FDA has decided no OPJ device since 2007.

Median 510(k) review, days · OPJ

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

Recalls per year · OPJ

No recall names OPJ since 2007.

Adverse event reports per year · OPJ

1in 2024

2007high 9 (2020) · low 0 (2007)2025

MAUDE reports naming product code OPJ, 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	—	0
2019	—	0
2020	—	9
2021	—	6
2022	—	3
2023	—	1
2024	—	1
2025	—	0
2026	—	—

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

Planning a device in OPJ? 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 880.6250.

LYZ Vinyl Patient Examination Glove LZA Polymer Patient Examination Glove OIG Powder-Free Guayle Rubber Examination Glove OPC Powder-Free Polychloroprene Patient…PWV Delivery Room Apparel Kit PXD Prep Kit LZC Medical Glove, Specialty PWP Blood Borne Pathogen Response Kit LYY Latex Patient Examination Glove PXC Personal Protection Kit PWT Chemotherapy Spill Clean-Up Kit LZB Finger Cot