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FDA 510(k)

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs

Numéro K : K163146 · 2017-02-13

DemandeurHebei Hongsen Plastics Technology Co, Ltd.
Date de décision2017-02-13
Code produitLZC
Comité consultatifHO
DécisionSubstantially Equivalent

Résumé du dispositif

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Hongsen Plastics Technology Co, Ltd.. It received FDA 510(k) clearance on 2017-02-13 under 510(k) number K163146. 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 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs?

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-02-13. The listed applicant is Hebei Hongsen Plastics Technology Co, Ltd.. The 510(k) number is K163146.

When did POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2017-02-13, under 510(k) number K163146.

Who is the listed applicant for POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs?

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

What is the FDA product code for POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs?

The FDA product code for POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is LZC.

Essais cliniques associés

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.

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Dispositifs connexes (Code : LZC)

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.

K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealthK243959Powder 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 BhdK220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.

Source officielle

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