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FDA 510(k)

Blue Nitrile Powder Free Patient Examination Glove, Non Sterile

K-Number: K210366 · 2021-05-07

Decision Date2021-05-07
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Blue Nitrile Powder Free Patient Examination Glove, Non Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Onetexx Sdn Bhd. It received FDA 510(k) clearance on 2021-05-07 under 510(k) number K210366. 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 Blue Nitrile Powder Free Patient Examination Glove, Non Sterile?

Blue Nitrile Powder Free Patient Examination Glove, Non Sterile is a medical device that received FDA 510(k) clearance on 2021-05-07. The listed applicant is Onetexx Sdn Bhd. The 510(k) number is K210366.

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

Blue Nitrile Powder Free Patient Examination Glove, Non Sterile received FDA 510(k) clearance on 2021-05-07, under 510(k) number K210366.

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

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

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Onetexx Sdn Bhd as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 7 devices →

Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.