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FDA 510(k)

Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)

K-Number: K250496 · 2025-07-07

ApplicantZibo Shengkun Chemical Industry Co., Ltd.
Decision Date2025-07-07
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Shengkun Chemical Industry Co., Ltd.. It received FDA 510(k) clearance on 2025-07-07 under 510(k) number K250496. 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 Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)?

Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) is a medical device that received FDA 510(k) clearance on 2025-07-07. The listed applicant is Zibo Shengkun Chemical Industry Co., Ltd.. The 510(k) number is K250496.

When did Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) receive FDA 510(k) clearance?

Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) received FDA 510(k) clearance on 2025-07-07, under 510(k) number K250496.

Who is the listed applicant for Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)?

The FDA 510(k) record lists Zibo Shengkun Chemical Industry Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)?

The FDA product code for Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) 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.

NCT07629427Green or Pink? A Comparison of Pain and Procedural Difficulty With Intravenous Cannulas in the Emergency DepartmentCOMPLETEDNCT07682883The Importance of Mucosal Screening in the Prevention of Oral Cancer.ENROLLING_BY_INVITATION

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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