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FDA 510(k)

Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves

K-Nummer: K171737 · 2017-12-29

AntragstellerAnsell Healthcare Products, LLC
Entscheidungsdatum2017-12-29
ProduktcodeLZA
BeratungsausschussHO
EntscheidungSubstantially Equivalent

Produktübersicht

Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2017-12-29 under 510(k) number K171737. 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 Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves?

Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2017-12-29. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K171737.

When did Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves receive FDA 510(k) clearance?

Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves received FDA 510(k) clearance on 2017-12-29, under 510(k) number K171737.

Who is the listed applicant for Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves?

The FDA 510(k) record lists Ansell Healthcare Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves?

The FDA product code for Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves is LZA.

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Weitere Einträge mit Ansell Healthcare Products, LLC als Antragsteller

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

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Verwandte Geräte (Code: LZA)

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

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 CitrateCardinalhealthK260794NON-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 BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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