Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)— 510(k) K203036
Substantially EquivalentCentral Medicare Sdn Bhd
FDA 510(k) clearance K203036 for Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors), Substantially Equivalent on 2021-05-07. Applicant: Central Medicare Sdn Bhd.
Clearance details
- Applicant
- Central Medicare Sdn Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Teluk Intan, 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.