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FDA 510(k)

PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove

Número K: K231973 · 2023-09-29

RequerenteIneo Tech Sdn Bhd
Data da decisão2023-09-29
Código do produtoKGO
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove is the device name listed in this FDA 510(k) record. The listed applicant is Ineo Tech Sdn Bhd. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K231973. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove?

PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Ineo Tech Sdn Bhd. The 510(k) number is K231973.

When did PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove receive FDA 510(k) clearance?

PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove received FDA 510(k) clearance on 2023-09-29, under 510(k) number K231973.

Who is the listed applicant for PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove?

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

What is the FDA product code for PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove?

The FDA product code for PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove is KGO.

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