Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution— 510(k) K252117
Substantially EquivalentSw Technologies, Inc.
FDA 510(k) clearance K252117 for Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution, Substantially Equivalent on 2026-06-24. Applicant: Sw Technologies, Inc.. Device class: 1.
Summary
Sw Technologies' device name describes a biodegradable, powder-free nitrile examination glove in blue. It's filed under LZA, polymer patient examination gloves. The name also says it was tested for use with chemotherapy drugs, fentanyl citrate, simulated gastric acid, and fentanyl citrate-simulated gastric acid solution; the record gives no test results.
Class I, 21 CFR 880.6250. General Hospital is both the classification panel and the review panel, and it came in as a Special 510(k).
The applicant filed from Union City, California. The decision came 352 calendar days after FDA received it (July 7, 2025 to June 24, 2026).
Clearance details
- Applicant
- Sw Technologies, Inc.
- Product code
- Product code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Union City, CA, US
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Adverse events under product code LZA
product code LZA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.