Phoenix Glove Co.: FDA clearances and approvals
Phoenix Glove Co. has 6 FDA 510(k) clearances (first 1978, latest 1983), across 5 product codes in 3 review panels. Median 510(k) review time: 36 days.
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 |
|---|---|---|---|
| FMC | Patient Examination Glove | 2 | 2 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| FJZ | Declotting Tray, Kit (Including Contents) | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Review panels
Most recent Phoenix Glove Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K830660 | STERILE SURGICAL DRAPES | KKX | 1983-03-17 | 15 |
| K821044 | PATIENT PREP KITS/TRAYS-STERILE | FRG | 1982-06-23 | 70 |
| K821666 | STERILE SURGICAL DRAPES | FJZ | 1982-06-21 | 14 |
| K821043 | STERILE PATIENT EXAM. GLOVES | FMC | 1982-05-21 | 37 |
| K801846 | ELECTROCARDIOGRAPH ELECTRODE | DRX | 1980-09-09 | 36 |
| K781820 | GLOVES, VINYL EXAMINATION | FMC | 1978-12-07 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Phoenix Glove Co..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Phoenix Glove Co. have?
Phoenix Glove Co. has 6 FDA 510(k) clearances (first 1978, latest 1983), across 5 product codes in 3 review panels.
How long does FDA take to clear Phoenix Glove Co.'s 510(k)s?
The median time from FDA receipt to decision across Phoenix Glove Co.'s cleared 510(k)s is 36 days.
What devices does Phoenix Glove Co. make?
Its most frequent FDA product codes are FMC (Patient Examination Glove, 2); DRX (Electrode, Electrocardiograph, 1); FJZ (Declotting Tray, Kit (Including Contents), 1).
Has Phoenix Glove Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Phoenix Glove Co. Related entities may recall under other names.
Next steps
- See all 6 Phoenix Glove Co. clearances with predicates and recalls
- Run predicate analysis for product code FMC, Phoenix Glove Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.