Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate— 510(k) K234097
Substantially EquivalentEver Growth (Vietnam) Corporation Limited
FDA 510(k) clearance K234097 for Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Substantially Equivalent on 2024-03-27. Applicant: Ever Growth (Vietnam) Corporation Limited. Device class: 1.
Clearance details
- Applicant
- Ever Growth (Vietnam) Corporation Limited
- 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
- Traditional
- Location
- Long Khanh City, VN
Recent devices under product code LZA
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- K261793 — Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
- K262542 — Biodegradable Nitrile Powder Free Examination Glove, Green +1 more
- K260312 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim +1 more
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.