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FDA 510(k)

Disposable Nitrile Medical Powder-free Glove

K-Nummer: K213187 · 2022-01-03

AntragstellerFujian Chunhui Medical Supply Co., Ltd.
Entscheidungsdatum2022-01-03
ProduktcodeLZA
BeratungsausschussHO
EntscheidungSubstantially Equivalent

Produktübersicht

Disposable Nitrile Medical Powder-free Glove is the device name listed in this FDA 510(k) record. The listed applicant is Fujian Chunhui Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2022-01-03 under 510(k) number K213187. 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 Nitrile Medical Powder-free Glove?

Disposable Nitrile Medical Powder-free Glove is a medical device that received FDA 510(k) clearance on 2022-01-03. The listed applicant is Fujian Chunhui Medical Supply Co., Ltd.. The 510(k) number is K213187.

When did Disposable Nitrile Medical Powder-free Glove receive FDA 510(k) clearance?

Disposable Nitrile Medical Powder-free Glove received FDA 510(k) clearance on 2022-01-03, under 510(k) number K213187.

Who is the listed applicant for Disposable Nitrile Medical Powder-free Glove?

The FDA 510(k) record lists Fujian Chunhui Medical Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Nitrile Medical Powder-free Glove?

The FDA product code for Disposable Nitrile Medical Powder-free Glove 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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