FDA applicant
Inner Mongolia Cureguard Medical Technology Co., Ltd.
FDA records 3 decisions for Inner Mongolia Cureguard Medical Technology Co., Ltd. (Baotou, CN) from 2021 to 2022: 3 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 3 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 Inner Mongolia Cureguard Medical Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Inner Mongolia Cureguard Medical…’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 “Inner”
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