FDA 510(k)

Nitrile Examination Gloves (Powder free, Blue)

N.º K: K213029 · 2021-12-14

SolicitanteWeihai Hongyu Nonwoven Fabric Products Co., Ltd.

Fecha de decisión2021-12-14

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Nitrile Examination Gloves (Powder free, Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Weihai Hongyu Nonwoven Fabric Products Co., Ltd.. It received FDA 510(k) clearance on 2021-12-14 under 510(k) number K213029. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Nitrile Examination Gloves (Powder free, Blue)?

Nitrile Examination Gloves (Powder free, Blue) is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is Weihai Hongyu Nonwoven Fabric Products Co., Ltd.. The 510(k) number is K213029.

When did Nitrile Examination Gloves (Powder free, Blue) receive FDA 510(k) clearance?

Nitrile Examination Gloves (Powder free, Blue) received FDA 510(k) clearance on 2021-12-14, under 510(k) number K213029.

Who is the listed applicant for Nitrile Examination Gloves (Powder free, Blue)?

The FDA 510(k) record lists Weihai Hongyu Nonwoven Fabric Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Examination Gloves (Powder free, Blue)?

The FDA product code for Nitrile Examination Gloves (Powder free, Blue) is LZA.

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Otros registros que enlistan a Weihai Hongyu Nonwoven Fabric Products Co., Ltd. como solicitante

K214088Disposable Surgical Gown K220133Sterilization Wraps K212807Surgical Masks

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.

Fuente oficial

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