Fitco Dipped Products Pvt., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Fitco Dipped Products Pvt., Ltd.” (first 1999, latest 2000), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 34 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 4 | 4 |
| KGO | Surgeon'S Gloves | 2 | 2 |
Review panels
- General Hospital (6)
Most recent Fitco Dipped Products Pvt., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001715 | POWDERED PATIENT EXAMINATION GLOVES, LATEX | LYY | 2000-07-05 | 30 |
| K001232 | NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS | LYY | 2000-05-15 | 28 |
| K000896 | POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS | KGO | 2000-05-03 | 44 |
| K001216 | POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 2000-04-28 | 14 |
| K000891 | STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES | LYY | 2000-04-28 | 39 |
| K993450 | LATEX SURGICAL GLOVES, PRE-POWDERED | KGO | 1999-12-29 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Fitco Dipped Products Pvt., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Fitco Dipped Products Pvt., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Fitco Dipped Products Pvt., Ltd.” (first 1999, latest 2000), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fitco Dipped Products Pvt., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fitco Dipped Products Pvt., Ltd. is 34 days.
Which FDA product codes appear under Fitco Dipped Products Pvt., Ltd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 4); KGO (Surgeon'S Gloves, 2).
Next steps
- See all 6 Fitco Dipped Products Pvt., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Fitco Dipped Products Pvt., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.