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FDA 510(k)

DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES

K-Number: K935869 · 1994-02-24

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1994-02-24
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEXTREN(TM) POWDER FREE HYPOALLERGENIC 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 1994-02-24 under 510(k) number K935869. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES?

DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES is a medical device that received FDA 510(k) clearance on 1994-02-24. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K935869.

When did DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES receive FDA 510(k) clearance?

DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES received FDA 510(k) clearance on 1994-02-24, under 510(k) number K935869.

Who is the listed applicant for DEXTREN(TM) POWDER FREE HYPOALLERGENIC 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 DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES?

The FDA product code for DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES is KGO.

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Related Devices (Code: KGO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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