SBG Blue Nitrile Powder Free Medical Examination Glove— 510(k) K180467
Substantially EquivalentShowa Best Glove, Inc.
FDA 510(k) clearance K180467 for SBG Blue Nitrile Powder Free Medical Examination Glove, Substantially Equivalent on 2018-10-10. Applicant: Showa Best Glove, Inc.. Device class: 1.
Clearance details
- Applicant
- Showa Best Glove, Inc.
- Product code
- Product 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
- Menlo, GA, US
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More clearances from Showa Best Glove, Inc.
view allAdverse 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.