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FDA 510(k)

Powdered Free Sterile Natural Rubber Latex Surgical Gloves

Numéro K : K230832 · 2023-08-16

DemandeurThe Egyptian Company For Medical & Electronic Industries
Date de décision2023-08-16
Code produitKGO
Comité consultatifSU
DécisionSubstantially Equivalent

Résumé du dispositif

Powdered Free Sterile Natural Rubber Latex Surgical Gloves is the device name listed in this FDA 510(k) record. The listed applicant is The Egyptian Company For Medical & Electronic Industries. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K230832. 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 Powdered Free Sterile Natural Rubber Latex Surgical Gloves?

Powdered Free Sterile Natural Rubber Latex Surgical Gloves is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is The Egyptian Company For Medical & Electronic Industries. The 510(k) number is K230832.

When did Powdered Free Sterile Natural Rubber Latex Surgical Gloves receive FDA 510(k) clearance?

Powdered Free Sterile Natural Rubber Latex Surgical Gloves received FDA 510(k) clearance on 2023-08-16, under 510(k) number K230832.

Who is the listed applicant for Powdered Free Sterile Natural Rubber Latex Surgical Gloves?

The FDA 510(k) record lists The Egyptian Company For Medical & Electronic Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powdered Free Sterile Natural Rubber Latex Surgical Gloves?

The FDA product code for Powdered Free Sterile Natural Rubber Latex Surgical Gloves 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 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.

Source officielle

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