FDA 510(k)

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White

Numéro K : K190725 · 2019-12-17

Date de décision2019-12-17

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White 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 2019-12-17 under 510(k) number K190725. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White?

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White is a medical device that received FDA 510(k) clearance on 2019-12-17. The listed applicant is Riverstone Resources Sdn Bhd. The 510(k) number is K190725.

When did Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White receive FDA 510(k) clearance?

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White received FDA 510(k) clearance on 2019-12-17, under 510(k) number K190725.

Who is the listed applicant for Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White?

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 Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White?

The FDA product code for Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White is LZA.

Essais cliniques associés

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Autres dossiers indiquant Riverstone Resources Sdn Bhd en tant que demandeur

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 K200326Powder Free Nitrile Examination Glove (Aqua Green)K180452White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim

Dispositifs connexes (Code : 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.

Source officielle

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