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FDA 510(k)

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs

K-Nummer: K171276 · 2017-08-21

AntragstellerTg Medical Sdn. Bhd.
Entscheidungsdatum2017-08-21
ProduktcodeKGO
BeratungsausschussSU
EntscheidungSubstantially Equivalent

Produktübersicht

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Tg Medical Sdn. Bhd.. It received FDA 510(k) clearance on 2017-08-21 under 510(k) number K171276. 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 Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs?

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-08-21. The listed applicant is Tg Medical Sdn. Bhd.. The 510(k) number is K171276.

When did Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2017-08-21, under 510(k) number K171276.

Who is the listed applicant for Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Tg Medical Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs?

The FDA product code for Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs is KGO.

Zugehörige klinische Studien

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.

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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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