Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile— 510(k) K221378
Substantially EquivalentTec Gloves Industry (M) Sdn.Bhd.
FDA 510(k) clearance K221378 for Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Substantially Equivalent on 2022-09-30. Applicant: Tec Gloves Industry (M) Sdn.Bhd..
Clearance details
- Applicant
- Tec Gloves Industry (M) Sdn.Bhd.
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Klang, 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.