FDA 510(k)

Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove

Numéro K : K203236 · 2021-08-16

Date de décision2021-08-16

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove 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 2021-08-16 under 510(k) number K203236. 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 Health Non-Sterile, Powder-free Nitrile Exam Glove?

Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove is a medical device that received FDA 510(k) clearance on 2021-08-16. The listed applicant is Rhino Health, Inc.. The 510(k) number is K203236.

When did Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove receive FDA 510(k) clearance?

Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove received FDA 510(k) clearance on 2021-08-16, under 510(k) number K203236.

Who is the listed applicant for Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove?

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 Health Non-Sterile, Powder-free Nitrile Exam Glove?

The FDA product code for Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove 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 K221082Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl

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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