FDA applicant
Better Care Plastic Technology Co., Ltd.
FDA records 11 decisions for Better Care Plastic Technology Co., Ltd. (Shenze County, CN) from 2014 to 2025: 11 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and KGO (Surgeon'S Gloves). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 101 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 3 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 Better Care Plastic Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Better Care Plastic Technology 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) ReportOther applicant names beginning “Better”
FDA records each applicant name separately; these may or may not be the same firm.