ORTHOPEDIC SURGICAL GLOVE— 510(k) K831564
Substantially EquivalentAnsell, Inc.
FDA 510(k) clearance K831564 for ORTHOPEDIC SURGICAL GLOVE, Substantially Equivalent on 1983-07-12. Applicant: Ansell, Inc.. Device class: 1.
Clearance details
- Applicant
- Ansell, Inc.
- Product code
- Code FMC
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dothan, AL, US
Recent devices under product code FMC
view all- K042618 — LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)
- K014134 — POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)
- K992337 — BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA
- K932404 — NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE
- K932405 — NITRILE RUBBER EXAMINATION GLOVES (POWERED)
More clearances from Ansell, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.