FDA 510(k)

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves

Numéro K : K221748 · 2022-09-13

DemandeurGuilin Hbm Health Protections, Inc.

Date de décision2022-09-13

Code produitKGO

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Hbm Health Protections, Inc.. It received FDA 510(k) clearance on 2022-09-13 under 510(k) number K221748. 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 Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves?

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is Guilin Hbm Health Protections, Inc.. The 510(k) number is K221748.

When did Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves receive FDA 510(k) clearance?

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves received FDA 510(k) clearance on 2022-09-13, under 510(k) number K221748.

Who is the listed applicant for Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves?

The FDA 510(k) record lists Guilin Hbm Health Protections, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves?

The FDA product code for Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves is KGO.

Essais cliniques associés

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Autres dossiers indiquant Guilin Hbm Health Protections, Inc. en tant que demandeur

K203483Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves

Dispositifs connexes (Code : KGO)

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 Limited K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbH K240790Polyisoprene 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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