FDA 510(k)

POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE

K-Number: K122874 · 2012-12-10

ApplicantNitrilist Gloves Manufacturing Sdn Bhd

Decision Date2012-12-10

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE is the device name listed in this FDA 510(k) record. The listed applicant is Nitrilist Gloves Manufacturing Sdn Bhd. It received FDA 510(k) clearance on 2012-12-10 under 510(k) number K122874. 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 POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE?

POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE is a medical device that received FDA 510(k) clearance on 2012-12-10. The listed applicant is Nitrilist Gloves Manufacturing Sdn Bhd. The 510(k) number is K122874.

When did POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE receive FDA 510(k) clearance?

POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE received FDA 510(k) clearance on 2012-12-10, under 510(k) number K122874.

Who is the listed applicant for POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE?

The FDA 510(k) record lists Nitrilist Gloves Manufacturing Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE?

The FDA product code for POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE is LZA.

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Other records listing Nitrilist Gloves Manufacturing Sdn Bhd as applicant

K123328POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK

Related Devices (Code: LZA)

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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.