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FDA 510(k)

YULEX LATEX POWDER-FREE EXAM GLOVES

K-Number: K063810 · 2008-04-18

ApplicantYulex Corporation
Decision Date2008-04-18
Product CodeOIG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

YULEX LATEX POWDER-FREE EXAM GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Yulex Corporation. It received FDA 510(k) clearance on 2008-04-18 under 510(k) number K063810. The device is classified under product code OIG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YULEX LATEX POWDER-FREE EXAM GLOVES?

YULEX LATEX POWDER-FREE EXAM GLOVES is a medical device that received FDA 510(k) clearance on 2008-04-18. The listed applicant is Yulex Corporation. The 510(k) number is K063810.

When did YULEX LATEX POWDER-FREE EXAM GLOVES receive FDA 510(k) clearance?

YULEX LATEX POWDER-FREE EXAM GLOVES received FDA 510(k) clearance on 2008-04-18, under 510(k) number K063810.

Who is the listed applicant for YULEX LATEX POWDER-FREE EXAM GLOVES?

The FDA 510(k) record lists Yulex Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YULEX LATEX POWDER-FREE EXAM GLOVES?

The FDA product code for YULEX LATEX POWDER-FREE EXAM GLOVES is OIG.

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Official Source

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

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