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FDA 510(k)

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)

K-Number: K230314 · 2023-08-16

ApplicantNew Era Medicare Sdn. Bhd.
Decision Date2023-08-16
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) is a medical device manufactured by New Era Medicare Sdn. Bhd.. It received FDA 510(k) clearance on 2023-08-16 under approval number K230314. 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 Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)?

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) is a medical device that received FDA 510(k) clearance on 2023-08-16. It is manufactured by New Era Medicare Sdn. Bhd.. The 510(k) number is K230314.

When was Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) approved by the FDA?

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) received FDA 510(k) clearance on 2023-08-16, under approval number K230314.

What company makes Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)?

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) is manufactured by New Era Medicare Sdn. Bhd..

What is the FDA product code for Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)?

The FDA product code for Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) is LZA.

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Other Devices by New Era Medicare Sdn. Bhd.

K221667Non Sterile Powder Free Latex Examination Glove K221424Sterile Surgical Powder Free Latex Glove

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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