FDA product code · General hospital

Powder-Free Polychloroprene Patient Examination Glove

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

OPCClass I21 CFR 880.6250510(k) required1 decision since 20210 recalls

1 FDA decision since 2021. 510(k) reviews decided 2021–2025 took a median of 57 days (half between 57 and 57). No recall names this code.

A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

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 OPC 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 · OPC

1in 2021

2007high 1 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OPC

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

Recalls per year · OPC

No recall names OPC since 2007.

Adverse event reports per year · OPC

1in 2023

2007high 1 (2021) · low 0 (2007)2025

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

View these four charts as a table

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

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

Planning a device in OPC? 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

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Other codes under 21 CFR 880.6250.

LYZ Vinyl Patient Examination Glove LZA Polymer Patient Examination Glove OIG Powder-Free Guayle Rubber Examination Glove 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 OPJ Medical Gloves With Chemotherapy Labeling…PWT Chemotherapy Spill Clean-Up Kit LZB Finger Cot

Powder-Free Polychloroprene Patient Examination Glove

What has FDA decided in OPC lately?

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