Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl— 510(k) K200539
Substantially EquivalentSri Trang Gloves (Thailand) Public Company Limited
FDA 510(k) clearance K200539 for Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl, Substantially Equivalent on 2020-04-09. Applicant: Sri Trang Gloves (Thailand) Public Company Limited.
Clearance details
- Applicant
- Sri Trang Gloves (Thailand) Public Company Limited
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Hatyai, TH
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.