White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim— 510(k) K180452
Substantially EquivalentRiverstone Resources Sdn Bhd
FDA 510(k) clearance K180452 for White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim, Substantially Equivalent on 2018-06-12. Applicant: Riverstone Resources Sdn Bhd.
Clearance details
- Applicant
- Riverstone Resources Sdn Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bukit Beruntung, MY
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.