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FDA 510(k)

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves

K-Nummer: K211209 · 2021-12-17

AntragstellerHycare International Co., Ltd.
Entscheidungsdatum2021-12-17
ProduktcodeLZA
BeratungsausschussHO
EntscheidungSubstantially Equivalent

Produktübersicht

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Hycare International Co., Ltd.. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K211209. 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 Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves?

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Hycare International Co., Ltd.. The 510(k) number is K211209.

When did Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves receive FDA 510(k) clearance?

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves received FDA 510(k) clearance on 2021-12-17, under 510(k) number K211209.

Who is the listed applicant for Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves?

The FDA 510(k) record lists Hycare International Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves?

The FDA product code for Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves is LZA.

Zugehörige klinische Studien

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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