Dermoaroma Disposable Nitrile Examination Glove— 510(k) K212716
Substantially EquivalentChuzhou Harmony Gloves Medical Technology Co.,Ltd
FDA 510(k) clearance K212716 for Dermoaroma Disposable Nitrile Examination Glove, Substantially Equivalent on 2021-12-27. Applicant: Chuzhou Harmony Gloves Medical Technology Co.,Ltd.
Clearance details
- Applicant
- Chuzhou Harmony Gloves Medical Technology Co.,Ltd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chuzhou, CN
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.