FDA 510(k)

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl

Numéro K : K221082 · 2022-11-30

Date de décision2022-11-30

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl is the device name listed in this FDA 510(k) record. The listed applicant is Rhino Health, Inc.. It received FDA 510(k) clearance on 2022-11-30 under 510(k) number K221082. 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 Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl?

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl is a medical device that received FDA 510(k) clearance on 2022-11-30. The listed applicant is Rhino Health, Inc.. The 510(k) number is K221082.

When did Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl receive FDA 510(k) clearance?

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl received FDA 510(k) clearance on 2022-11-30, under 510(k) number K221082.

Who is the listed applicant for Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl?

The FDA 510(k) record lists Rhino Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl?

The FDA product code for Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl is LZA.

Essais cliniques associés

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Autres dossiers indiquant Rhino Health, Inc. en tant que demandeur

K223859Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl K203236Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove

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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