FDA applicant
Perusahaan Getah Asas Sdn. Bhd.
FDA records 30 decisions for Perusahaan Getah Asas Sdn. Bhd. (Gambrills, MD) from 1989 to 2010: 30 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Perusahaan Getah Asas Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2026 so far, outlined.
Recalls per year
4in 2011
Class I Class II/III not classified
Planning a device like Perusahaan Getah Asas 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) ReportOther applicant names beginning “Perusahaan”
FDA records each applicant name separately; these may or may not be the same firm.