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FDA 510(k)

Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

Numéro K : K250313 · 2025-08-19

DemandeurHarps Europe Manufacturing GmbH
Date de décision2025-08-19
Code produitKGO
Comité consultatifSU
DécisionSubstantially Equivalent

Résumé du dispositif

Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is the device name listed in this FDA 510(k) record. The listed applicant is Harps Europe Manufacturing GmbH. It received FDA 510(k) clearance on 2025-08-19 under 510(k) number K250313. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid?

Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a medical device that received FDA 510(k) clearance on 2025-08-19. The listed applicant is Harps Europe Manufacturing GmbH. The 510(k) number is K250313.

When did Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid receive FDA 510(k) clearance?

Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid received FDA 510(k) clearance on 2025-08-19, under 510(k) number K250313.

Who is the listed applicant for Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid?

The FDA 510(k) record lists Harps Europe Manufacturing GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid?

The FDA product code for Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is KGO.

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 : KGO)

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.

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 LimitedK240790Polyisoprene 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.K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)Ansell Healthcare

Source officielle

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