FDA 510(k)

Powder Free Nitrile Examination Glove (Aqua Green)

Número K: K200326 · 2020-04-09

Data da decisão2020-04-09

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Powder Free Nitrile Examination Glove (Aqua Green) is the device name listed in this FDA 510(k) record. The listed applicant is Riverstone Resources Sdn Bhd. It received FDA 510(k) clearance on 2020-04-09 under 510(k) number K200326. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Powder Free Nitrile Examination Glove (Aqua Green)?

Powder Free Nitrile Examination Glove (Aqua Green) is a medical device that received FDA 510(k) clearance on 2020-04-09. The listed applicant is Riverstone Resources Sdn Bhd. The 510(k) number is K200326.

When did Powder Free Nitrile Examination Glove (Aqua Green) receive FDA 510(k) clearance?

Powder Free Nitrile Examination Glove (Aqua Green) received FDA 510(k) clearance on 2020-04-09, under 510(k) number K200326.

Who is the listed applicant for Powder Free Nitrile Examination Glove (Aqua Green)?

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

What is the FDA product code for Powder Free Nitrile Examination Glove (Aqua Green)?

The FDA product code for Powder Free Nitrile Examination Glove (Aqua Green) is LZA.

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Outros registros que listam Riverstone Resources Sdn Bhd como candidato(a)

K220672Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim K220401Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim K190725Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White K180452White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim

Dispositivos Relacionados (Código: LZA)

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 CitrateCardinalhealth K260794NON-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 Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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