Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fitco Dipped Products Pvt., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
78 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001715 | POWDERED PATIENT EXAMINATION GLOVES, LATEX | Fitco Dipped Products Pvt., Ltd. | 2000-07-05 | 30 | 0 |
| K001232 | NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEI | Fitco Dipped Products Pvt., Ltd. | 2000-05-15 | 28 | 0 |
| K000896 | POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAI | Fitco Dipped Products Pvt., Ltd. | 2000-05-03 | 44 | 0 |
| K000891 | STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES | Fitco Dipped Products Pvt., Ltd. | 2000-04-28 | 39 | 0 |
| K001216 | POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PR | Fitco Dipped Products Pvt., Ltd. | 2000-04-28 | 14 | 0 |
| K993450 | LATEX SURGICAL GLOVES, PRE-POWDERED | Fitco Dipped Products Pvt., Ltd. | 1999-12-29 | 78 | 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