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FDA 510(k)

Biodegradable Thermoplastic Elastomer Examination (TPE) Glove

Número K: K202078 · 2021-03-05

RequerenteShen Wei USA, Inc.
Data da decisão2021-03-05
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Biodegradable Thermoplastic Elastomer Examination (TPE) Glove 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 2021-03-05 under 510(k) number K202078. 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 Thermoplastic Elastomer Examination (TPE) Glove?

Biodegradable Thermoplastic Elastomer Examination (TPE) Glove is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K202078.

When did Biodegradable Thermoplastic Elastomer Examination (TPE) Glove receive FDA 510(k) clearance?

Biodegradable Thermoplastic Elastomer Examination (TPE) Glove received FDA 510(k) clearance on 2021-03-05, under 510(k) number K202078.

Who is the listed applicant for Biodegradable Thermoplastic Elastomer Examination (TPE) Glove?

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 Thermoplastic Elastomer Examination (TPE) Glove?

The FDA product code for Biodegradable Thermoplastic Elastomer Examination (TPE) Glove 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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