Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves— 510(k) K171737
Substantially EquivalentAnsell Healthcare Products, LLC
FDA 510(k) clearance K171737 for Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves, Substantially Equivalent on 2017-12-29. Applicant: Ansell Healthcare Products, LLC. Device class: 1.
Clearance details
- Applicant
- Ansell Healthcare Products, LLC
- Product code
- Code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Iselin, NJ, US
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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.