GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)— 510(k) K240545
Substantially EquivalentGenabio Diagnostics, Inc.
FDA 510(k) clearance K240545 for GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL), Substantially Equivalent on 2024-08-28. Applicant: Genabio Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Genabio Diagnostics, Inc.
- Product code
- Code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
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More clearances from Genabio Diagnostics, Inc.
view allAdverse 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.