FDA 510(k)

Halyard Black-Orange Powder-Free Nitrile Exam Glove

Numéro K : K153708 · 2016-03-31

Date de décision2016-03-31

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Halyard Black-Orange Powder-Free Nitrile Exam Glove is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health. It received FDA 510(k) clearance on 2016-03-31 under 510(k) number K153708. 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 Halyard Black-Orange Powder-Free Nitrile Exam Glove?

Halyard Black-Orange Powder-Free Nitrile Exam Glove is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Halyard Health. The 510(k) number is K153708.

When did Halyard Black-Orange Powder-Free Nitrile Exam Glove receive FDA 510(k) clearance?

Halyard Black-Orange Powder-Free Nitrile Exam Glove received FDA 510(k) clearance on 2016-03-31, under 510(k) number K153708.

Who is the listed applicant for Halyard Black-Orange Powder-Free Nitrile Exam Glove?

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

What is the FDA product code for Halyard Black-Orange Powder-Free Nitrile Exam Glove?

The FDA product code for Halyard Black-Orange Powder-Free Nitrile Exam Glove is LZA.

Essais cliniques associés

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Autres dossiers indiquant Halyard Health en tant que demandeur

K181360ON-Q* Pump with Bolus K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves

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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