FDA applicant
Lpl (Hui Zhou) Glove
FDA records 2 decisions for Lpl (Hui Zhou) Glove (Huizhou City, CN) from 2011 to 2015: 2 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Lpl (Hui Zhou) Glove Co., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Lpl (Hui Zhou) Glove’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Lpl (Hui Zhou) Glove’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