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FDA 510(k)

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

Numéro K : K180476 · 2018-05-15

DemandeurComfort Rubber Gloves Industries Sdn. Bhd.
Date de décision2018-05-15
Code produitLZC
Comité consultatifHO
DécisionSubstantially Equivalent

Résumé du dispositif

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2018-05-15 under 510(k) number K180476. 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 Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs?

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2018-05-15. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. The 510(k) number is K180476.

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

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2018-05-15, under 510(k) number K180476.

Who is the listed applicant for Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Comfort Rubber Gloves Industries Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Powder Free Nitrile Examination 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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Autres dossiers indiquant Comfort Rubber Gloves Industries Sdn. Bhd. en tant que demandeur

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.

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinK240269Nitrile Powder Free Examination Gloves Biodegradable (Green)K241528Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis PotentialK192954Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and FentanylK200181Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK190080Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)

Voir tous les 9 dispositifs →

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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