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FDA 510(k)

Disposable Medical Examination Nitrile Gloves

K-Nummer: K232008 · 2023-08-08

AntragstellerRaxwell Industrial, LLC
Entscheidungsdatum2023-08-08
ProduktcodeLZA
BeratungsausschussHO
EntscheidungSubstantially Equivalent

Produktübersicht

Disposable Medical Examination Nitrile Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Raxwell Industrial, LLC. It received FDA 510(k) clearance on 2023-08-08 under 510(k) number K232008. 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 Disposable Medical Examination Nitrile Gloves?

Disposable Medical Examination Nitrile Gloves is a medical device that received FDA 510(k) clearance on 2023-08-08. The listed applicant is Raxwell Industrial, LLC. The 510(k) number is K232008.

When did Disposable Medical Examination Nitrile Gloves receive FDA 510(k) clearance?

Disposable Medical Examination Nitrile Gloves received FDA 510(k) clearance on 2023-08-08, under 510(k) number K232008.

Who is the listed applicant for Disposable Medical Examination Nitrile Gloves?

The FDA 510(k) record lists Raxwell Industrial, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Examination Nitrile Gloves?

The FDA product code for Disposable Medical Examination Nitrile Gloves is LZA.

Zugehörige klinische Studien

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.

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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.

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