FDA 510(k)

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)

Numéro K : K222642 · 2022-09-20

DemandeurInner Mongolia Cureguard Medical Technology Co., Ltd.

Date de décision2022-09-20

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) is the device name listed in this FDA 510(k) record. The listed applicant is Inner Mongolia Cureguard Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-09-20 under 510(k) number K222642. 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 Examination Glove(Tested for use with Chemotherapy Drug)?

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Inner Mongolia Cureguard Medical Technology Co., Ltd.. The 510(k) number is K222642.

When did Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) receive FDA 510(k) clearance?

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) received FDA 510(k) clearance on 2022-09-20, under 510(k) number K222642.

Who is the listed applicant for Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)?

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

What is the FDA product code for Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)?

The FDA product code for Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) is LZA.

Essais cliniques associés

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Autres dossiers indiquant Inner Mongolia Cureguard Medical Technology Co., Ltd. en tant que demandeur

K212661Disposable Nitrile Examination Glove K212401Disposable Nitrile Examination Glove

Dispositifs connexes (Code : 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.

Source officielle

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