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FDA 510(k)

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color

Número K: K162312 · 2017-07-25

RequerenteShen Wei USA, Inc.
Data da decisão2017-07-25
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2017-07-25 under 510(k) number K162312. 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 Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color?

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is a medical device that received FDA 510(k) clearance on 2017-07-25. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K162312.

When did Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color receive FDA 510(k) clearance?

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color received FDA 510(k) clearance on 2017-07-25, under 510(k) number K162312.

Who is the listed applicant for Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color?

The FDA 510(k) record lists Shen Wei USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color?

The FDA product code for Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is LZA.

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Dispositivos Relacionados (Código: LZA)

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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.

Fonte oficial

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