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FDA 510(k)

Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs

K-Number: K214110 · 2022-02-19

ApplicantMah Sing Healthcare Sdn. Bhd.
Decision Date2022-02-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Mah Sing Healthcare Sdn. Bhd.. It received FDA 510(k) clearance on 2022-02-19 under 510(k) number K214110. 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 Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs?

Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2022-02-19. The listed applicant is Mah Sing Healthcare Sdn. Bhd.. The 510(k) number is K214110.

When did Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs receive FDA 510(k) clearance?

Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs received FDA 510(k) clearance on 2022-02-19, under 510(k) number K214110.

Who is the listed applicant for Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs?

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

What is the FDA product code for Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs?

The FDA product code for Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs 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 CancerRECRUITINGNCT06823440Prevention of CIPN Using Compressive TherapyRECRUITINGNCT07247825Efficacy of Therapeutic Percutaneous Electrolysis Simple vs Multifiliar Therapy in Supraspinatus Tendinopathy.RECRUITINGNCT07546279The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.RECRUITINGNCT07695792Efficacy of Therapeutic Percutaneous Electrolysis Simple vs Multiple vs Laser Therapy in Supraspinatus Tendinopathy.COMPLETEDNCT05623696Effect of Non-invasive Magnetic Stimulation of the Brain on Breathlessness in Healthy Individuals.COMPLETED

Other records listing Mah Sing Healthcare 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.

K243694Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - BlueK230002Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy DrugsK223415Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK212535Nitrile Powder Free Blue Examination Gloves, Non-Sterile

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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