Intl. Trade Management Co.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Intl. Trade Management Co.” (first 1995, latest 1995), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 60 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 Intl. Trade Management Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954462 | POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES | KGO | 1995-10-13 | 18 |
| K953299 | POLYKOTE | LYY | 1995-08-07 | 24 |
| K951513 | JAI | LYY | 1995-05-25 | 52 |
| K950468 | POWDER FREE STERILE LATEX SURGEONS GLOVES | KGO | 1995-04-25 | 81 |
| K950467 | POWDER FREE PATIENT EXAMINATION GLOVES | LYY | 1995-04-25 | 81 |
| K946203 | JAI POWDERFREE LATEX EXAMINATION GLOVES | LYY | 1995-02-27 | 68 |
Recalls
openFDA lists no recalls under a recalling firm named Intl. Trade Management Co..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Intl. Diagnostic Technology (29 510(k)s)
- Intl. Immunoassay Laboratories, Inc. (27 510(k)s)
- Intl. Medical, Inc. (17 510(k)s)
- Intl. Remote Imaging Systems (14 510(k)s)
- Intl. Medical Devices , Ltd. (12 510(k)s)
- Intl. Playtex, Inc. (10 510(k)s)
- Intl. Business Machines (8 510(k)s)
- Intl. Bioclinical, Inc. (6 510(k)s)
- Intl. Diagnostic, Inc. (6 510(k)s)
- Intl. Medical Consultants (6 510(k)s)
- Intl. Medical Equipment Corp. (6 510(k)s)
- Intl. Ophthalmic Industries Corp. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intl. Trade Management Co.?
FDA lists 6 510(k) clearances under the applicant name “Intl. Trade Management Co.” (first 1995, latest 1995), 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 Intl. Trade Management Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intl. Trade Management Co. is 60 days.
Which FDA product codes appear under Intl. Trade Management Co.?
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 Intl. Trade Management Co. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Intl. Trade Management Co.'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.