FDA 510(k)

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential

Номер K: K191860 · 2020-03-31

ЗаявительSemperit Technische Produkte Gesellchaft M.B.H.

Дата решения2020-03-31

Код продуктаKGO

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential is the device name listed in this FDA 510(k) record. The listed applicant is Semperit Technische Produkte Gesellchaft M.B.H.. It received FDA 510(k) clearance on 2020-03-31 under 510(k) number K191860. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential?

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential is a medical device that received FDA 510(k) clearance on 2020-03-31. The listed applicant is Semperit Technische Produkte Gesellchaft M.B.H.. The 510(k) number is K191860.

When did Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential receive FDA 510(k) clearance?

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential received FDA 510(k) clearance on 2020-03-31, under 510(k) number K191860.

Who is the listed applicant for Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential?

The FDA 510(k) record lists Semperit Technische Produkte Gesellchaft M.B.H. 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 Glove with Low Dermatitis Potential?

The FDA product code for Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential is KGO.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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.

Официальный источник

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