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FDA 510(k)

NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

K-Number: K083156 · 2009-05-08

ApplicantGiga-Drive Sdn, Bhd
Decision Date2009-05-08
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE is the device name listed in this FDA 510(k) record. The listed applicant is Giga-Drive Sdn, Bhd. It received FDA 510(k) clearance on 2009-05-08 under 510(k) number K083156. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE?

NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE is a medical device that received FDA 510(k) clearance on 2009-05-08. The listed applicant is Giga-Drive Sdn, Bhd. The 510(k) number is K083156.

When did NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE receive FDA 510(k) clearance?

NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE received FDA 510(k) clearance on 2009-05-08, under 510(k) number K083156.

Who is the listed applicant for NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE?

The FDA 510(k) record lists Giga-Drive Sdn, Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE?

The FDA product code for NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE is LZA.

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Related Devices (Code: LZA)

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

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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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