Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Fitone Latex Products Co., Ltd. Guangdong · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231446 | Single-Use Latex Sterile Surgical Gloves (SG100) | Fitone Latex Products Co., Ltd. Guangdong | 2023-09-22 | 127 | 0 |
| K221747 | Nitrile Patient Examination Gloves Tested For Use With Chemo | Fitone Latex Products Co., Ltd. Guangdong | 2022-12-01 | 168 | 0 |
| K222693 | Single-use medical latex examination gloves (LG100) | Fitone Latex Products Co., Ltd. Guangdong | 2022-09-24 | 18 | 0 |
| K211927 | Nitrile examination gloves | Fitone Latex Products Co., Ltd. Guangdong | 2021-10-12 | 112 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda