Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color— 510(k) K202080
Substantially EquivalentShen Wei USA, Inc.
FDA 510(k) clearance K202080 for Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color, Substantially Equivalent on 2021-03-24. Applicant: Shen Wei USA, Inc.. Device class: 1.
Clearance details
- Applicant
- Shen Wei USA, Inc.
- 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
- Union City, CA, US
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More clearances from Shen Wei USA, Inc.
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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.