# Aspen Glove Sdn. Bhd.

- Location (FDA's records): Georgetown, MY
- FDA decisions: 4 (2021–2021): 4 510(k) clearances
- Product codes: LZA (1), LZC (1), LYY (1), KGO (1)
- 510(k) review time since 2016: median 127 days, against 150 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Jr Engineering & Medical Technologies (M) Sdn. Bhd.: 3 (https://510kreport.com/company/jr-engineering-medical-technologies-m-sdn-bhd)
- Harbour Health, LLC: 1 (https://510kreport.com/company/harbour-health)

## Recent decisions
- K213076: AspenMed+ (Dec 20, 2021)
- K211477: Latex Examination Powder Free Gloves (Sep 20, 2021)
- K211479: Blue Nitrile Examination Glove Powder Free (Sep 16, 2021)
- K211478: Sterile Latex Surgical Gloves Powder Free (Sep 16, 2021)

Source page: https://510kreport.com/company/aspen-glove-sdn-bhd