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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 a medical device manufactured by Tec Gloves Industry (M) Sdn.Bhd.. It received FDA 510(k) clearance on 2022-09-30 under approval 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. It is manufactured by Tec Gloves Industry (M) Sdn.Bhd.. The 510(k) number is K221378.

When was Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile approved by the FDA?

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

What company makes Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile?

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile is manufactured by Tec Gloves Industry (M) Sdn.Bhd..

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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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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