Proclean - Nitrile Powder Free Examination Gloves— 510(k) K211374
Substantially EquivalentDr.Boo Company Limited
FDA 510(k) clearance K211374 for Proclean - Nitrile Powder Free Examination Gloves, Substantially Equivalent on 2021-10-13. Applicant: Dr.Boo Company Limited.
Clearance details
- Applicant
- Dr.Boo Company Limited
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sriracha, TH
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.