FDA applicant
Perusahaan Pelindung Getah (M) Sdn Bhd
FDA records 8 decisions for Perusahaan Pelindung Getah (M) Sdn Bhd (Sembilan Darul Khusus Malaysia, ML) from 1989 to 2008: 8 510(k) clearances. All are in product code 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 Perusahaan Pelindung Getah (M) Sdn Bhd’s devices, and how often a recall has named them.
FDA decisions per year
1in 2008
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Perusahaan Pelindung Getah (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) ReportOther applicant names beginning “Perusahaan”
FDA records each applicant name separately; these may or may not be the same firm.