Barriermed Glove Co.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Barriermed Glove Co.” (first 1999, latest 2006), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 77 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 |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 4 | 4 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Barriermed Glove Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053406 | BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES | KGO | 2006-07-05 | 210 |
| K061038 | BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490 | KGO | 2006-06-23 | 70 |
| K052772 | BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES | KGO | 2005-12-20 | 78 |
| K052892 | SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55 | LZA | 2005-11-30 | 47 |
| K990710 | BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES | KGO | 1999-05-20 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Barriermed Glove 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.
- Barriermed, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Barriermed Glove Co.?
FDA lists 5 510(k) clearances under the applicant name “Barriermed Glove Co.” (first 1999, latest 2006), 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 Barriermed Glove Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Barriermed Glove Co. is 77 days.
Which FDA product codes appear under Barriermed Glove Co.?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 4); LZA (Polymer Patient Examination Glove, 1).
Next steps
- See all 5 Barriermed Glove Co. clearances with predicates and recalls
- Run predicate analysis for product code KGO, Barriermed Glove 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.