General Gloves Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “General Gloves Corp.” (first 1998, latest 2003), across 1 product code in 1 review panel. Median 510(k) review time under this name: 52 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 General Gloves Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K024338 | POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE | LYZ | 2003-03-03 | 66 |
| K024174 | NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES | LYZ | 2003-01-28 | 41 |
| K010830 | POWDER FREE TEXTURED VINYL EXAMINATION GLOVES | LYZ | 2001-04-09 | 20 |
| K010829 | POWDER FREE ELASTIC VINYL EXAMINATION GLOVES | LYZ | 2001-04-05 | 16 |
| K992107 | BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES | LYZ | 1999-08-23 | 62 |
| K982933 | VINYL EXAMINATION GLOVES, POWDER FREE | LYZ | 1998-11-06 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named General Gloves Corp..
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.
- General Electric Co. (254 510(k)s)
- General Diagnostics (39 510(k)s)
- General Electric Medical Systems Information Techn (33 510(k)s)
- General Biometrics, Inc. (23 510(k)s)
- General Medical Co. (15 510(k)s)
- General Surgical Innovations (14 510(k)s)
- General X-Ray, Inc. (14 510(k)s)
- General Devices (13 510(k)s)
- General Physiotherapy, Inc. (9 510(k)s)
- General Medical Merate S.P.A (7 510(k)s)
- General Theraphysical, Inc. (7 510(k)s)
- General Atomics (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under General Gloves Corp.?
FDA lists 6 510(k) clearances under the applicant name “General Gloves Corp.” (first 1998, latest 2003), 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 General Gloves Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name General Gloves Corp. is 52 days.
Which FDA product codes appear under General Gloves Corp.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 6).
Next steps
- See all 6 General Gloves Corp. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, General Gloves Corp.'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.