FDA applicant

Hartalega Snd. Bhd.

Bandar Sri Damansara, MY2 decisions2012–20160 recalls

FDA records 2 decisions for Hartalega Snd. Bhd. (Bandar Sri Damansara, MY) from 2012 to 2016: 2 510(k) clearances. 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 Hartalega Snd. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Hartalega Snd. Bhd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hartalega Snd. Bhd.’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 “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 Sdb. Bhd. 4

Hartalega Snd. Bhd.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Hartalega”