Entscheidungsdatum2021-10-31
ProduktcodeLZA
BeratungsausschussHO
EntscheidungSubstantially Equivalent
Produktübersicht
Black 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 2021-10-31 under 510(k) number K210588. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Häufig gestellte Fragen
What is the Black Nitrile Powder Free Patient Examination Glove, Non Sterile?
Black Nitrile Powder Free Patient Examination Glove, Non Sterile is a medical device that received FDA 510(k) clearance on 2021-10-31. The listed applicant is Onetexx Sdn Bhd. The 510(k) number is K210588.
When did Black Nitrile Powder Free Patient Examination Glove, Non Sterile receive FDA 510(k) clearance?
Black Nitrile Powder Free Patient Examination Glove, Non Sterile received FDA 510(k) clearance on 2021-10-31, under 510(k) number K210588.
Who is the listed applicant for Black 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 Black Nitrile Powder Free Patient Examination Glove, Non Sterile?
The FDA product code for Black Nitrile Powder Free Patient Examination Glove, Non Sterile is LZA.
Zugehörige klinische Studien
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Weitere Einträge mit Onetexx Sdn Bhd als Antragsteller
Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.
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 AcidK210775White Nitrile Powder Free Patient Examination Glove, Non SterileK210587Violet Nitrile Powder Free Patient Examination Glove, Non SterileK210366Blue Nitrile Powder Free Patient Examination Glove, Non Sterile Alle 7 Geräte anzeigen →
Verwandte Geräte (Code: LZA)
Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.
K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealthK260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.
Offizielle Quelle
In der FDA-Datenbank anzeigen →Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.