Summit Glove, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Summit Glove, Inc.” (first 2010, latest 2022), across 1 product code in 1 review panel. Median 510(k) review time under this name: 228 days. Since 2017 the median was 63 days, against 112 days for all cleared 510(k)s in the same product codes. 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 | 3 | 63 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Summit Glove, Inc. took a median 63 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 5 | 5 |
Review panels
- General Hospital (5)
Most recent Summit Glove, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220371 | Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) | LZA | 2022-11-02 | 266 |
| K220375 | Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) | LZA | 2022-04-13 | 63 |
| K220373 | Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) | LZA | 2022-04-13 | 63 |
| K093517 | NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE | LZA | 2010-06-29 | 228 |
| K093516 | NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES | LZA | 2010-06-29 | 228 |
Recalls
openFDA lists no recalls under a recalling firm named Summit Glove, 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.
- Summit Medical, Inc. (14 510(k)s)
- Summit World Trade Corp. (10 510(k)s)
- Summit Industries, Inc. (8 510(k)s)
- Summit Doppler Systems, Inc. (7 510(k)s)
- Summit Nuclear (6 510(k)s)
- Summit Technology, Inc. (5 510(k)s)
- Summit Medical Products, Inc. (4 510(k)s)
- Summit Medventures (2 510(k)s)
- Summit Optics, Inc. (2 510(k)s)
- Summit Spine (2 510(k)s)
- Summit Access, LLC (1 510(k)s)
- Summit Durable Medical Equipment, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Summit Glove, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Summit Glove, Inc.” (first 2010, latest 2022), 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 Summit Glove, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Summit Glove, Inc. is 228 days. Since 2017: 63 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Summit Glove, Inc.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 5).
Next steps
- See all 5 Summit Glove, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Summit Glove, 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.