BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE— 510(k) K050184
Substantially EquivalentRegent Medical Americas, LLC
FDA 510(k) clearance K050184 for BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE, Substantially Equivalent on 2005-03-16. Applicant: Regent Medical Americas, LLC. Device class: 1.
Clearance details
- Applicant
- Regent Medical Americas, LLC
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norcross, GA, US
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More clearances from Regent Medical Americas, LLC
view all- K053441 — BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE
- K053102 — BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE
- K053442 — BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
- K053443 — BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE
- K050899 — BIOGEL LATEX STERILE POWDER-FREE GLOVE
Data sourced from openFDA. This site is unofficial and independent of the FDA.