FDA applicant
Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.
FDA records 5 decisions for Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. (Selangor Darul Ehsan, MY) from 1989 to 1995: 5 510(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 Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Shield Gloves Manufacturer 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 “Shield”
FDA records each applicant name separately; these may or may not be the same firm.