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FDA 510(k)

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)

Numéro K : K214056 · 2022-09-20

DemandeurMezorrison Medical Technology (Dongying) Co., Ltd.
Date de décision2022-09-20
Code produitLZA
Comité consultatifHO
DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Mezorrison Medical Technology (Dongying) Co., Ltd.. It received FDA 510(k) clearance on 2022-09-20 under 510(k) number K214056. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)?

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Mezorrison Medical Technology (Dongying) Co., Ltd.. The 510(k) number is K214056.

When did Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) receive FDA 510(k) clearance?

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2022-09-20, under 510(k) number K214056.

Who is the listed applicant for Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)?

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

What is the FDA product code for Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)?

The FDA product code for Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) is LZA.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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.

Source officielle

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