FDA applicant

Meditech Gloves Sdn Bhd

Nilai, MY2 decisions2021–20220 recalls

FDA records 2 decisions for Meditech Gloves Sdn Bhd (Nilai, MY) from 2021 to 2022: 2 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Meditech Gloves Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2021high 1 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Meditech Gloves Sdn Bhd by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Meditech Gloves Sdn Bhd’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 “Meditech”

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

Meditech Spine, LLC 10 Meditech International, Inc. 5 Meditech, Inc. 3 Meditech Kft. 2 Meditech Advisors, LLC 2 Meditech Endoscopy, Ltd. 1

Meditech Gloves Sdn Bhd

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Meditech”