Cleared Traditional

K935917 - CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES
(FDA 510(k) Clearance)

K935917 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Anesthesiology device

Feb 1994

Decision

56d

Days

Class 1

Risk

K935917 is an FDA 510(k) clearance for the CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES. This device is classified as a Mask, Oxygen, Non-rebreathing (Class I - General Controls, product code KGB).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on February 4, 1994, 56 days after receiving the submission on December 10, 1993.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5570.

Submission Details

510(k) Number	K935917 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 10, 1993
Decision Date	February 04, 1994
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF