FDA 510(k)

Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid

Número K: K243133 · 2025-06-17

RequerenteKl-Kepong Rubber Products Sdn. Bhd.

Data da decisão2025-06-17

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid is the device name listed in this FDA 510(k) record. The listed applicant is Kl-Kepong Rubber Products Sdn. Bhd.. It received FDA 510(k) clearance on 2025-06-17 under 510(k) number K243133. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid?

Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid is a medical device that received FDA 510(k) clearance on 2025-06-17. The listed applicant is Kl-Kepong Rubber Products Sdn. Bhd.. The 510(k) number is K243133.

When did Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid receive FDA 510(k) clearance?

Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid received FDA 510(k) clearance on 2025-06-17, under 510(k) number K243133.

Who is the listed applicant for Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid?

The FDA 510(k) record lists Kl-Kepong Rubber Products Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid?

The FDA product code for Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid is LZA.

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Outros registros que listam Kl-Kepong Rubber Products Sdn. Bhd. como candidato(a)

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