FDA 510(k) clearance · back to tracker

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

Basic Medical Technology, Inc. cleared K250630 on 2025-05-22, decision: substantially equivalent

K-number

K250630

Sponsor

Basic Medical Technology, Inc.

Device

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

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-05-22

Product code

LZA

Advisory committee

General Hospital

Medical specialty

General Hospital

Regulation number

880.6250

Official FDA record

Open K250630on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Drop K250630 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.