DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM— 510(k) K013302
Substantially EquivalentAllegiance Healthcare Corp.
FDA 510(k) clearance K013302 for DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM, Substantially Equivalent on 2001-12-17. Applicant: Allegiance Healthcare Corp.. Device class: 1.
Clearance details
- Applicant
- Allegiance Healthcare Corp.
- 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
- Mcgaw Park, IL, US
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More clearances from Allegiance Healthcare Corp.
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Data sourced from openFDA. This site is unofficial and independent of the FDA.