FDA applicant
5r Med Instruments (Chengdu) Co., Ltd.
FDA records 2 decisions for 5r Med Instruments (Chengdu) Co., Ltd. (Chengdu, CN) in 2021: 2 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 5r Med Instruments (Chengdu) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like 5r Med Instruments (Chengdu) Co., Ltd.’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