STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE— 510(k) K171093
Substantially EquivalentSanrea Healthcare Products Pvt, Ltd.
FDA 510(k) clearance K171093 for STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE, Substantially Equivalent on 2017-07-19. Applicant: Sanrea Healthcare Products Pvt, Ltd..
Clearance details
- Applicant
- Sanrea Healthcare Products Pvt, Ltd.
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palakkad, IN
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.