Basic Medical Technology, Inc.: FDA clearances and approvals
Basic Medical Technology, Inc. has 8 FDA 510(k) clearances (first 2025, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 82 days. Since 2017 its median was 82 days, against 109 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2025 | 6 | 82 |
| 2026 | 2 | 70 |
Review time against the same product codes
Since 2017, Basic Medical Technology, Inc.'s cleared 510(k)s took a median 82 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 6 | 6 |
| LYZ | Vinyl Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (8)
Most recent Basic Medical Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260860 | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | LYZ | 2026-04-07 | 22 |
| K253160 | Syntex Exam Gloves | LZA | 2026-01-23 | 119 |
| K252505 | Powder-Free Vinyl Exam Gloves, clear | LYZ | 2025-08-28 | 20 |
| K251716 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | LZA | 2025-08-27 | 84 |
| K250193 | Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) | LZA | 2025-07-09 | 167 |
| K250630 | Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | LZA | 2025-05-22 | 80 |
| K243792 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) | LZA | 2025-02-18 | 70 |
| K243441 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) | LZA | 2025-01-31 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Basic Medical Technology, Inc..
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 Basic Medical Technology, Inc. have?
Basic Medical Technology, Inc. has 8 FDA 510(k) clearances (first 2025, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Basic Medical Technology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Basic Medical Technology, Inc.'s cleared 510(k)s is 82 days. Since 2017: 82 days, versus 109 days for all cleared 510(k)s in the same product codes.
What devices does Basic Medical Technology, Inc. make?
Its most frequent FDA product codes are LZA (Polymer Patient Examination Glove, 6); LYZ (Vinyl Patient Examination Glove, 2).
Has Basic Medical Technology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Basic Medical Technology, Inc. Related entities may recall under other names.
Next steps
- See all 8 Basic Medical Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Basic Medical Technology, Inc.'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.