FDA applicant

Aspen Glove Sdn. Bhd.

Georgetown, MY4 decisions2021–20210 recalls

FDA records 4 decisions for Aspen Glove Sdn. Bhd. (Georgetown, MY) in 2021: 4 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LZC (Medical Glove, Specialty). Since 2016 its 510(k)s took a median of 127 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 4 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 Aspen Glove Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2021

2021high 4 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Aspen Glove Sdn. Bhd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aspen Glove Sdn. 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 “Aspen”

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

Aspen Laboratories, Inc. 55 Aspen Labs 6 Aspen Surgical Products, Inc. 2 Aspen Laser Systems, LLC 2 Aspen Imaging Healthcare, Inc. 2 Aspen Medical, Ltd. 1

Aspen Glove Sdn. Bhd.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Aspen”