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FDA 510(k)

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)

K-Number: K222642 · 2022-09-20

ApplicantInner Mongolia Cureguard Medical Technology Co., Ltd.
Decision Date2022-09-20
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) is the device name listed in this FDA 510(k) record. The listed applicant is Inner Mongolia Cureguard Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-09-20 under 510(k) number K222642. 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 Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)?

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Inner Mongolia Cureguard Medical Technology Co., Ltd.. The 510(k) number is K222642.

When did Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) receive FDA 510(k) clearance?

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) received FDA 510(k) clearance on 2022-09-20, under 510(k) number K222642.

Who is the listed applicant for Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)?

The FDA 510(k) record lists Inner Mongolia Cureguard Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)?

The FDA product code for Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) 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.

NCT07546279The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.RECRUITINGNCT07579611Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral NeuropathyNOT_YET_RECRUITING

Other records listing Inner Mongolia Cureguard Medical Technology Co., Ltd. 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.

K212661Disposable Nitrile Examination GloveK212401Disposable Nitrile Examination Glove

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

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