Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (K251716)
Description
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate by Basic Medical Technology, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251716
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (K251716) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250630 | Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and t... | Basic Medical Technology, Inc. | 2025 |
| K212408 | Powder Free Nitrile Examination Gloves (Tested for Use with... | Pt. Maja Agung Latexindo | 2022 |
Trace the full predicate network for K251716
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.