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FDA 510(k)

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

K-Number: K243133 · 2025-06-17

ApplicantKl-Kepong Rubber Products Sdn. Bhd.
Decision Date2025-06-17
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Kl-Kepong Rubber Products Sdn. Bhd.. The 510(k) number is K243133.

When was Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid approved by the FDA?

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 approval number K243133.

What company makes 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 manufactured by Kl-Kepong Rubber Products Sdn. Bhd..

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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Related PubMed Literature

PMID: 42024289 Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan. Journal of medical systems (2026) PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025) PMID: 41123878 Medical devices in Europe, all but drugs: time to radically change their regulation? Internal and emergency medicine (2026) PMID: 41085780 Evaluation of nickel release from Ni-Ti stents in various media for safety assessment purposes. Journal of materials science. Materials in medicine (2025)

Other Devices by Kl-Kepong Rubber Products Sdn. Bhd.

K220118Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves

Related Devices (Code: LZA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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