FDA applicant
La Glove (M) Sdn. Bhd.
FDA records 22 decisions for La Glove (M) Sdn. Bhd. (Kajang Selangpr D.E., MY) from 1991 to 2010: 22 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and 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
How often FDA has decided La Glove (M) Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2010
2007high 2 (2009) · low 0 (2007)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like La Glove (M) 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