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FDA 510(k)

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)

K-Number: K211310 · 2021-06-16

ApplicantMegine Industries Sdn Bhd
Decision Date2021-06-16
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) is a medical device manufactured by Megine Industries Sdn Bhd. It received FDA 510(k) clearance on 2021-06-16 under approval number K211310. 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 AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)?

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) is a medical device that received FDA 510(k) clearance on 2021-06-16. It is manufactured by Megine Industries Sdn Bhd. The 510(k) number is K211310.

When was AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) approved by the FDA?

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) received FDA 510(k) clearance on 2021-06-16, under approval number K211310.

What company makes AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)?

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) is manufactured by Megine Industries Sdn Bhd.

What is the FDA product code for AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)?

The FDA product code for AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) is LZA.

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Other Devices by Megine Industries Sdn Bhd

K220232Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange

Related Devices (Code: LZA)

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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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