Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)— 510(k) K180505
Substantially EquivalentHartalega Sdn Bhd
FDA 510(k) clearance K180505 for Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White), Substantially Equivalent on 2018-06-14. Applicant: Hartalega Sdn Bhd.
Clearance details
- Applicant
- Hartalega Sdn Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bandar Sri Damansara, 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.