510(k) Report

FDA applicant

Unitex Latex Gloves, Inc.

Taipei, Taiwan, TW1 decision1989–19890 recalls

FDA records 1 decision for Unitex Latex Gloves, Inc. (Taipei, Taiwan, TW) in 1989: 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 Unitex Latex Gloves, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Unitex Latex Gloves, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Unitex Latex Gloves, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Unitex”

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