FDA applicant
Jiangsu Cureguard Glove Co., Ltd.
FDA records 11 decisions for Jiangsu Cureguard Glove Co., Ltd. (Suqian, CN) from 2007 to 2022: 11 510(k) clearances. Most are in product codes LYZ (Vinyl Patient Examination Glove) and LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 116 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Jiangsu Cureguard Glove Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
2in 2011
Class I Class II/III not classified
Planning a device like Jiangsu Cureguard Glove 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