Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)

K-Number: K211608 · 2021-08-05

ApplicantJiangsu Cureguard Glove Co., Ltd.
Decision Date2021-08-05
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Cureguard Glove Co., Ltd.. It received FDA 510(k) clearance on 2021-08-05 under 510(k) number K211608. 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 Medical Examination Glove (Tested for Use with Chemotherapy Drugs)?

Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-08-05. The listed applicant is Jiangsu Cureguard Glove Co., Ltd.. The 510(k) number is K211608.

When did Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) receive FDA 510(k) clearance?

Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2021-08-05, under 510(k) number K211608.

Who is the listed applicant for Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)?

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

What is the FDA product code for Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)?

The FDA product code for Disposable Nitrile Medical Examination Glove (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.

NCT07546279The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.RECRUITINGNCT07142304The Lilac Device Trial - IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy StudyRECRUITING

Other records listing Jiangsu Cureguard Glove 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.

K222937Disposable Nitrile Examination GloveK213121Disposable Nitrile Examination GloveK211354Disposable Synthetic Vinyl Nitrile Examination GloveK210691Disposable Nitrile Medical Examination GloveK210684Disposable Nitrile Medical 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

View on FDA Database →

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

↑