FDA 510(k)

Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

Numéro K : K212789 · 2021-12-01

Demandeur5r Med Instruments (Chengdu) Co., Ltd.

Date de décision2021-12-01

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is 5r Med Instruments (Chengdu) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-01 under 510(k) number K212789. 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 Examination Gloves (Tested for Use with Chemotherapy Drugs)?

Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-12-01. The listed applicant is 5r Med Instruments (Chengdu) Co., Ltd.. The 510(k) number is K212789.

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

Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2021-12-01, under 510(k) number K212789.

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

The FDA 510(k) record lists 5r Med Instruments (Chengdu) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Essais cliniques associés

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Autres dossiers indiquant 5r Med Instruments (Chengdu) Co., Ltd. en tant que demandeur

K210776Nitrile 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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