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FDA 510(k)

Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant

Numéro K : K210330 · 2022-03-04

DemandeurWrp Asia Pacific Sdn. Bhd.
Date de décision2022-03-04
Code produitLZA
Comité consultatifHO
DécisionSubstantially Equivalent

Résumé du dispositif

Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant is the device name listed in this FDA 510(k) record. The listed applicant is Wrp Asia Pacific Sdn. Bhd.. It received FDA 510(k) clearance on 2022-03-04 under 510(k) number K210330. 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 Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant?

Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant is a medical device that received FDA 510(k) clearance on 2022-03-04. The listed applicant is Wrp Asia Pacific Sdn. Bhd.. The 510(k) number is K210330.

When did Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant receive FDA 510(k) clearance?

Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant received FDA 510(k) clearance on 2022-03-04, under 510(k) number K210330.

Who is the listed applicant for Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant?

The FDA 510(k) record lists Wrp Asia Pacific Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant?

The FDA product code for Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant is LZA.

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 Wrp Asia Pacific 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.

K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylK232538DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYLK230578Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and FentanylK222058Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl ResistantK211601Powder Free Latex Examination Glove, Non-SterileK203030POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

Voir tous les 10 dispositifs →

Dispositifs connexes (Code : LZA)

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.

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 CitrateCardinalhealthK260794NON-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 BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Source officielle

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