FDA 510(k)

Nitrile examination gloves

Número K: K211927 · 2021-10-12

RequerenteFitone Latex Products Co., Ltd. Guangdong

Data da decisão2021-10-12

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile examination gloves is the device name listed in this FDA 510(k) record. The listed applicant is Fitone Latex Products Co., Ltd. Guangdong. It received FDA 510(k) clearance on 2021-10-12 under 510(k) number K211927. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Nitrile examination gloves?

Nitrile examination gloves is a medical device that received FDA 510(k) clearance on 2021-10-12. The listed applicant is Fitone Latex Products Co., Ltd. Guangdong. The 510(k) number is K211927.

When did Nitrile examination gloves receive FDA 510(k) clearance?

Nitrile examination gloves received FDA 510(k) clearance on 2021-10-12, under 510(k) number K211927.

Who is the listed applicant for Nitrile examination gloves?

The FDA 510(k) record lists Fitone Latex Products Co., Ltd. Guangdong as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile examination gloves?

The FDA product code for Nitrile examination gloves is LZA.

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Outros registros que listam Fitone Latex Products Co., Ltd. Guangdong como candidato(a)

K231446Single-Use Latex Sterile Surgical Gloves (SG100)K221747Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs K222693Single-use medical latex examination gloves (LG100)

Dispositivos Relacionados (Código: 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.

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