FDA 510(k)

Nitrile Patient Examination gloves, Powderfree, Blue color

K-Nummer: K143477 · 2016-04-14

Entscheidungsdatum2016-04-14

ProduktcodeLZA

BeratungsausschussHO

EntscheidungSubstantially Equivalent

Produktübersicht

Nitrile Patient Examination gloves, Powderfree, Blue color is the device name listed in this FDA 510(k) record. The listed applicant is Primus Gloves Pvt Limited. It received FDA 510(k) clearance on 2016-04-14 under 510(k) number K143477. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Nitrile Patient Examination gloves, Powderfree, Blue color?

Nitrile Patient Examination gloves, Powderfree, Blue color is a medical device that received FDA 510(k) clearance on 2016-04-14. The listed applicant is Primus Gloves Pvt Limited. The 510(k) number is K143477.

When did Nitrile Patient Examination gloves, Powderfree, Blue color receive FDA 510(k) clearance?

Nitrile Patient Examination gloves, Powderfree, Blue color received FDA 510(k) clearance on 2016-04-14, under 510(k) number K143477.

Who is the listed applicant for Nitrile Patient Examination gloves, Powderfree, Blue color?

The FDA 510(k) record lists Primus Gloves Pvt Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Patient Examination gloves, Powderfree, Blue color?

The FDA product code for Nitrile Patient Examination gloves, Powderfree, Blue color is LZA.

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Weitere Einträge mit Primus Gloves Pvt Limited als Antragsteller

K170612STERILE VINYL EXAMINATION GLOVES, Powder Free K170515Sterile Nitrile Surgical Gloves, Powder-free

Verwandte Geräte (Code: LZA)

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitril Pulverfreies Untersuchungsgewand, Grün; Biodegradable Nitril Pulverfreies Untersuchungsgewand, Violett-Blau, getestet für die Verwendung mit 32 Chemotherapiearzneimitteln, Fentanyl und Durchlässigkeit gegen Magensäure.Top 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 Nitrilblaue Untersuchungsgloves getestet für die Verwendung mit Chemotherapiearzneimitteln und FentanylcitratCardinalhealth 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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