FDA 510(k)

Nitrile Patient Examination Glove

Numéro K : K210686 · 2021-07-21

DemandeurYunnan Huazhiyuan Medical Technology Co., Ltd.

Date de décision2021-07-21

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Nitrile Patient Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Yunnan Huazhiyuan Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-07-21 under 510(k) number K210686. 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 Nitrile Patient Examination Glove?

Nitrile Patient Examination Glove is a medical device that received FDA 510(k) clearance on 2021-07-21. The listed applicant is Yunnan Huazhiyuan Medical Technology Co., Ltd.. The 510(k) number is K210686.

When did Nitrile Patient Examination Glove receive FDA 510(k) clearance?

Nitrile Patient Examination Glove received FDA 510(k) clearance on 2021-07-21, under 510(k) number K210686.

Who is the listed applicant for Nitrile Patient Examination Glove?

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

What is the FDA product code for Nitrile Patient Examination Glove?

The FDA product code for Nitrile Patient Examination Glove is LZA.

Essais cliniques associés

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Autres dossiers indiquant Yunnan Huazhiyuan Medical Technology Co., Ltd. en tant que demandeur

K213051Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)K212002Synthetic Vinyl Examination Gloves K210799Powder Free Vinyl Patient Examination Gloves

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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