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FDA 510(k)

Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs

K-Nummer: K213289 · 2023-05-26

AntragstellerAnsell Healthcare Products, LLC
Entscheidungsdatum2023-05-26
ProduktcodeKGO
BeratungsausschussSU
EntscheidungSubstantially Equivalent

Produktübersicht

Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K213289. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs?

Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K213289.

When did Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs received FDA 510(k) clearance on 2023-05-26, under 510(k) number K213289.

Who is the listed applicant for Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs?

The FDA 510(k) record lists Ansell Healthcare Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs?

The FDA product code for Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs is KGO.

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Weitere Einträge mit Ansell Healthcare Products, LLC als Antragsteller

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

K230079Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis PotentialK212148Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy DrugsK210401Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK200671Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested forK190018Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy DrugsK182948Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs

Alle 14 Geräte anzeigen →

Verwandte Geräte (Code: KGO)

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.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 FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

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