FDA applicant

Perusahaan Intan Emas Sdn. Bhd.

56100 Kuala Lumpur, Malaysia, MY4 decisions1989–19980 recalls

FDA records 4 decisions for Perusahaan Intan Emas Sdn. Bhd. (56100 Kuala Lumpur, Malaysia, MY) from 1989 to 1998: 4 510(k) clearances. All are in product code LYY (Latex 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 Perusahaan Intan Emas Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Perusahaan Intan Emas Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Perusahaan Intan Emas Sdn. Bhd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Perusahaan Intan Emas Sdn. 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 “Perusahaan”

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

Perusahaan Getah Asas Sdn. Bhd. 30 Perusahaan Pelindung Getah (M) Sdn Bhd 8

Perusahaan Intan Emas Sdn. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Perusahaan”