510(k) Report

FDA applicant

Uniject Gloves Pcl

Chalmette, LA1 decision1998–19980 recalls

FDA records 1 decision for Uniject Gloves Pcl (Chalmette, LA) in 1998: 1 510(k) clearance. All are in product code LYY (Latex Patient Examination Glove). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Uniject Gloves Pcl’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Uniject Gloves Pcl since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Uniject”

FDA records each applicant name separately; these may or may not be the same firm.