510(k) Report

FDA applicant

Absolute Synthetic Technologies Malaysia Sdn. Bhd.

Kamunting, Taiping, Perak, MY3 decisions1997–19970 recalls

FDA records 3 decisions for Absolute Synthetic Technologies Malaysia Sdn. Bhd. (Kamunting, Taiping, Perak, MY) in 1997: 3 510(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 Absolute Synthetic Technologies Malaysia Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Absolute Synthetic Technologies Malaysia Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Absolute Synthetic Technologies Malaysia Sdn. Bhd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Absolute”

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