FDA applicant

Healthy Glove Co., Ltd.

Hat Yai, TH2 decisions2016–20170 recalls

FDA records 2 decisions for Healthy Glove Co., Ltd. (Hat Yai, TH) from 2016 to 2017: 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 Healthy Glove Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Healthy Glove Co., Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Healthy”

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

Healthy.Io, Ltd. 4 Healthy Sleep Dental Laboratory 1

Healthy Glove Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Healthy”