STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES— 510(k) K002933

Name: FDA 510(k) clearance K002933
Creator: U.S. Food and Drug Administration
Published: 2000-10-19

Substantially Equivalent

Maxxim Medical

FDA 510(k) clearance K002933 for STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES, Substantially Equivalent on 2000-10-19. Applicant: Maxxim Medical. Device class: 1.

Clearance details

Applicant: Maxxim Medical
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2000-09-20
Decision date: 2000-10-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hone Path, SC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.