Class Class I

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 (K250630)

K250630 2025-05-22 Traditional
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Description

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 by Basic Medical Technology, Inc., an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class I
510(k) NumberK250630
Clearance Date2025-05-22
Clearance TypeTraditional
Product CodeLZA
Regulation Number880.6250

Categories

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Predicate lineage for K250630

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 with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (K250630) cites 3 predicate devices and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K244034Disposable Powder Free Nitrile Examination Glove, Blue Colo...Ever Global (Vietnam) Enterprise Co...2025
K243441Nitrile Powder-Free Exam Gloves Tested for Use with Chemoth...Basic Medical Technology, Inc.2025
K231365Nitrile Patient Examination Gloves with Hyaluronic Acid Blu...Anhui Intco Medical Products Co., Ltd.2024

Later devices that cite this one as their predicate

Devices that cite K250630
K numberDeviceApplicantYear
K251716Nitrile Powder-Free Exam Gloves Tested for Use with Chemoth...Basic Medical Technology, Inc.2025

Trace the full predicate network for K250630

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.

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