FDA applicant

Hartalega Sdb. Bhd.

Bandar Sri Damansara, MY4 decisions2014–20170 recalls

FDA records 4 decisions for Hartalega Sdb. Bhd. (Bandar Sri Damansara, MY) from 2014 to 2017: 4 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and KGO (Surgeon'S Gloves). 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 Hartalega Sdb. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Hartalega Sdb. Bhd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hartalega Sdb. 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 “Hartalega”

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

Hartalega Sdn Bhd 61 Hartalega NGC Sdn. Bhd. 31 Hartalega Snd. Bhd. 2

Hartalega Sdb. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Hartalega”