FDA 510(k)

CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)

K-Number: K123116 · 2013-02-11

ApplicantWorldmed Manufacturing Sdn. Bhd.

Decision Date2013-02-11

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR) is the device name listed in this FDA 510(k) record. The listed applicant is Worldmed Manufacturing Sdn. Bhd.. It received FDA 510(k) clearance on 2013-02-11 under 510(k) number K123116. 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 CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)?

CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR) is a medical device that received FDA 510(k) clearance on 2013-02-11. The listed applicant is Worldmed Manufacturing Sdn. Bhd.. The 510(k) number is K123116.

When did CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR) receive FDA 510(k) clearance?

CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR) received FDA 510(k) clearance on 2013-02-11, under 510(k) number K123116.

Who is the listed applicant for CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)?

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

What is the FDA product code for CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)?

The FDA product code for CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR) is LZA.

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Other records listing Worldmed Manufacturing Sdn. Bhd. as applicant

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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.