Glormed Intl., Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Glormed Intl., Inc.” (first 1998, latest 2004), across 1 product code in 1 review panel. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Glormed Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041945 | POWDER-FREE BLUE VINYL EXAM GLOVES | LYZ | 2004-08-20 | 32 |
| K031104 | POWDERED VINYL EXAM GLOVES, WHITE | LYZ | 2003-06-10 | 64 |
| K021353 | POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE | LYZ | 2002-06-06 | 41 |
| K002340 | VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW | LYZ | 2000-08-22 | 21 |
| K983494 | VINYL EXAM GLOVES, POWDER FREE | LYZ | 1998-11-05 | 31 |
| K981360 | VINYL PATIENT EXAMINATION GLOVE, POWDERED | LYZ | 1998-10-15 | 184 |
Recalls
openFDA lists no recalls under a recalling firm named Glormed Intl., Inc..
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.
- Glormed Colombia S.A. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Glormed Intl., Inc.?
FDA lists 6 510(k) clearances under the applicant name “Glormed Intl., Inc.” (first 1998, latest 2004), across 1 product code 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 Glormed Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Glormed Intl., Inc. is 36 days.
Which FDA product codes appear under Glormed Intl., Inc.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 6).
Next steps
- See all 6 Glormed Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Glormed Intl., Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.