FDA applicant

Tk Hitech Technology Co., Ltd.

Tha Rang, Bangkok, TH1 decision2021–20210 recalls

FDA records 1 decision for Tk Hitech Technology Co., Ltd. (Tha Rang, Bangkok, TH) in 2021: 1 510(k) clearance. All are in product code LZA (Polymer 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 Tk Hitech Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Tk Hitech Technology Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Tk Hitech Technology Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?