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Walgreens

Model 295501 · WALGREEN CO. · DI 00311917006413

LYZ — Vinyl Patient Examination Glove · Class I · 21 CFR 880.6250

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

01122021-02: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 1.5/device2026-06: 0 reports for this device; peer average 1/device020506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-0201
2026-0501.5
2026-0601
This device (reports/month)Average device in LYZ (reports/device/month)

Regulatory clearances

  • K230046 SESE 2023-03-25 (k number procode)

Predicate lineage

K230046 — cites (transitively): K213006 (d1), K180861 (d2), K163168 (d3), K150224 (d4)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — WALGREEN CO.

Nothing in the loaded window.