Globe Ent., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Globe Ent., Inc.” (first 1989, latest 1997), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 138 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 2 | 2 |
| BRZ | Set, Blood Transfusion | 1 | 1 |
| KGO | Surgeon'S Gloves | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Globe Ent., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972854 | PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY | FPA | 1997-12-17 | 138 |
| K972839 | PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET | FPA | 1997-12-17 | 138 |
| K972843 | PROTOS BLOOD TRANSFUSION SET | BRZ | 1997-12-16 | 137 |
| K892623 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1989-09-11 | 154 |
| K884622 | SURGICAL GLOVES | KGO | 1989-03-14 | 130 |
Recalls
openFDA lists no recalls under a recalling firm named Globe Ent., 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.
- Globe Management Support, Inc. (2 510(k)s)
- Globe Safety Products, Inc. (2 510(k)s)
- Globe Safety Equipment, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Globe Ent., Inc.?
FDA lists 5 510(k) clearances under the applicant name “Globe Ent., Inc.” (first 1989, latest 1997), across 4 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 Globe Ent., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Globe Ent., Inc. is 138 days.
Which FDA product codes appear under Globe Ent., Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 2); BRZ (Set, Blood Transfusion, 1); KGO (Surgeon'S Gloves, 1).
Next steps
- See all 5 Globe Ent., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Globe Ent., 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, 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.