FDA 510(k)

CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES

K-Number: K935917 · 1994-02-04

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1994-02-04

Product CodeKGB

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1994-02-04 under 510(k) number K935917. The device is classified under product code KGB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES?

CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES is a medical device that received FDA 510(k) clearance on 1994-02-04. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K935917.

When did CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES receive FDA 510(k) clearance?

CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES received FDA 510(k) clearance on 1994-02-04, under 510(k) number K935917.

Who is the listed applicant for CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES?

The FDA product code for CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES is KGB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.