Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)— 510(k) K211620
Substantially EquivalentShen Wei USA, Inc.
FDA 510(k) clearance K211620 for Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less), Substantially Equivalent on 2021-08-19. Applicant: Shen Wei USA, Inc.. Device class: 1.
Clearance details
- Applicant
- Shen Wei USA, Inc.
- Product code
- Code LYY
- 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.