Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)— 510(k) K192232
Substantially EquivalentHartalega NGC Sdn. Bhd.
FDA 510(k) clearance K192232 for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White), Substantially Equivalent on 2019-11-08. Applicant: Hartalega NGC Sdn. Bhd..
Clearance details
- Applicant
- Hartalega NGC Sdn. Bhd.
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sepang, 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.