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FDA 510(k)

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

K-Number: K220118 · 2022-05-12

ApplicantKl-Kepong Rubber Products Sdn. Bhd.
Decision Date2022-05-12
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves 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 2022-05-12 under 510(k) number K220118. 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, Chemotherapy Nitrile Powder Free Examination Gloves?

Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-05-12. The listed applicant is Kl-Kepong Rubber Products Sdn. Bhd.. The 510(k) number is K220118.

When did Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves receive FDA 510(k) clearance?

Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves received FDA 510(k) clearance on 2022-05-12, under 510(k) number K220118.

Who is the listed applicant for Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves?

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, Chemotherapy Nitrile Powder Free Examination Gloves?

The FDA product code for Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves is LZA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06245603A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder CancerRECRUITING

Other records listing Kl-Kepong Rubber Products Sdn. Bhd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243133Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid

Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet BlueHartalega NGC Sdn. Bhd.K252117Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid SolutionSw Technologies, Inc.K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company LimitedK260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)Hartalega NGC Sdn. Bhd.K260806Nitrile Disposable Examination GlovesVista Industries,, LLC

Official Source

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