FDA 510(k)

Blue Nitrile Examination Glove Powder Free

Número K: K211479 · 2021-09-16

Data da decisão2021-09-16

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Blue Nitrile Examination Glove Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2021-09-16 under 510(k) number K211479. 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 Blue Nitrile Examination Glove Powder Free?

Blue Nitrile Examination Glove Powder Free is a medical device that received FDA 510(k) clearance on 2021-09-16. The listed applicant is Aspen Glove Sdn. Bhd.. The 510(k) number is K211479.

When did Blue Nitrile Examination Glove Powder Free receive FDA 510(k) clearance?

Blue Nitrile Examination Glove Powder Free received FDA 510(k) clearance on 2021-09-16, under 510(k) number K211479.

Who is the listed applicant for Blue Nitrile Examination Glove Powder Free?

The FDA 510(k) record lists Aspen Glove Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blue Nitrile Examination Glove Powder Free?

The FDA product code for Blue Nitrile Examination Glove Powder Free is LZA.

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Outros registros que listam Aspen Glove Sdn. Bhd. como candidato(a)

K213076AspenMed+K211477Latex Examination Powder Free Gloves K211478Sterile Latex Surgical Gloves Powder Free

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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