Decision Date2021-06-28
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Violet 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 2021-06-28 under 510(k) number K210587. 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 Violet Nitrile Powder Free Patient Examination Glove, Non Sterile?
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile is a medical device that received FDA 510(k) clearance on 2021-06-28. The listed applicant is Onetexx Sdn Bhd. The 510(k) number is K210587.
When did Violet Nitrile Powder Free Patient Examination Glove, Non Sterile receive FDA 510(k) clearance?
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile received FDA 510(k) clearance on 2021-06-28, under 510(k) number K210587.
Who is the listed applicant for Violet 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 Violet Nitrile Powder Free Patient Examination Glove, Non Sterile?
The FDA product code for Violet Nitrile Powder Free Patient Examination Glove, Non Sterile is LZA.
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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.
K222298Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric AcidK222294Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric AcidK221773Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric AcidK210588Black Nitrile Powder Free Patient Examination Glove, Non SterileK210775White Nitrile Powder Free Patient Examination Glove, Non SterileK210366Blue Nitrile Powder Free Patient Examination Glove, Non Sterile View all 7 devices →
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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.