Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis Potential— 510(k) K191860
Substantially EquivalentSemperit Technische Produkte Gesellchaft M.B.H.
FDA 510(k) clearance K191860 for Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis Potential, Substantially Equivalent on 2020-03-31. Applicant: Semperit Technische Produkte Gesellchaft M.B.H.. Device class: 1.
Clearance details
- Applicant
- Semperit Technische Produkte Gesellchaft M.B.H.
- 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
- Abbreviated
- Location
- Wimpassing, AT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.