FDA 510(k)

Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs

Numéro K : K220353 · 2022-03-31

Date de décision2022-03-31

Code produitLZC

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Niujian Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-03-31 under 510(k) number K220353. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs?

Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2022-03-31. The listed applicant is Niujian Technology Co., Ltd.. The 510(k) number is K220353.

When did Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2022-03-31, under 510(k) number K220353.

Who is the listed applicant for Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs?

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

What is the FDA product code for Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs?

The FDA product code for Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs is LZC.

Essais cliniques associés

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Autres dossiers indiquant Niujian Technology Co., Ltd. en tant que demandeur

K220354Disposable Medical Synthetic Nitrile Examination Gloves K210706Nitrile Examination Gloves

Dispositifs connexes (Code : LZC)

K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealth K243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)Better Care Plastic Technology Co., Ltd.K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn Bhd K220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.

Source officielle

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