FDA applicant
Bytech (Dongtai) Co., Ltd.
FDA records 2 decisions for Bytech (Dongtai) Co., Ltd. (Dongtai, CN) from 2013 to 2021: 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 “Bytech Dongtai Co., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bytech (Dongtai) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Bytech (Dongtai) 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