FDA 510(k)

JR.MEDIK Latex Surgeon’s Gloves Powder Free

Numéro K : K192328 · 2020-03-10

DemandeurJr Engineering & Medical Technologies (M) Sdn. Bhd.

Date de décision2020-03-10

Code produitKGO

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

JR.MEDIK Latex Surgeon’s Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2020-03-10 under 510(k) number K192328. 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 JR.MEDIK Latex Surgeon’s Gloves Powder Free?

JR.MEDIK Latex Surgeon’s Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2020-03-10. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K192328.

When did JR.MEDIK Latex Surgeon’s Gloves Powder Free receive FDA 510(k) clearance?

JR.MEDIK Latex Surgeon’s Gloves Powder Free received FDA 510(k) clearance on 2020-03-10, under 510(k) number K192328.

Who is the listed applicant for JR.MEDIK Latex Surgeon’s Gloves Powder Free?

The FDA 510(k) record lists Jr Engineering & Medical Technologies (M) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JR.MEDIK Latex Surgeon’s Gloves Powder Free?

The FDA product code for JR.MEDIK Latex Surgeon’s Gloves Powder Free is KGO.

Essais cliniques associés

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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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