FDA 510(k)

Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)

Número K: K163126 · 2017-02-22

Data da decisão2017-02-22

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) is the device name listed in this FDA 510(k) record. The listed applicant is Blue Sail Medical Co.,Ltd. It received FDA 510(k) clearance on 2017-02-22 under 510(k) number K163126. 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 Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)?

Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) is a medical device that received FDA 510(k) clearance on 2017-02-22. The listed applicant is Blue Sail Medical Co.,Ltd. The 510(k) number is K163126.

When did Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) received FDA 510(k) clearance on 2017-02-22, under 510(k) number K163126.

Who is the listed applicant for Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)?

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

What is the FDA product code for Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)?

The FDA product code for Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) is LZA.

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Outros registros que listam Blue Sail Medical Co.,Ltd como candidato(a)

K171782Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs

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.

Fonte oficial

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