FDA 510(k)

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile

K-Number: K221378 · 2022-09-30

ApplicantTec Gloves Industry (M) Sdn.Bhd.

Decision Date2022-09-30

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Tec Gloves Industry (M) Sdn.Bhd.. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K221378. 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 Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile?

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is Tec Gloves Industry (M) Sdn.Bhd.. The 510(k) number is K221378.

When did Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile receive FDA 510(k) clearance?

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile received FDA 510(k) clearance on 2022-09-30, under 510(k) number K221378.

Who is the listed applicant for Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile?

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

What is the FDA product code for Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile?

The FDA product code for Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile is LZA.

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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.