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 Medical Nitrile Examination Gloves - Non Sterile

K-Number: K221454 · 2022-07-12

Decision Date2022-07-12
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Nitrile Examination Gloves - Non Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Kangling Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-12 under 510(k) number K221454. 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 Medical Nitrile Examination Gloves - Non Sterile?

Disposable Medical Nitrile Examination Gloves - Non Sterile is a medical device that received FDA 510(k) clearance on 2022-07-12. The listed applicant is Guangzhou Kangling Biotechnology Co., Ltd.. The 510(k) number is K221454.

When did Disposable Medical Nitrile Examination Gloves - Non Sterile receive FDA 510(k) clearance?

Disposable Medical Nitrile Examination Gloves - Non Sterile received FDA 510(k) clearance on 2022-07-12, under 510(k) number K221454.

Who is the listed applicant for Disposable Medical Nitrile Examination Gloves - Non Sterile?

The FDA 510(k) record lists Guangzhou Kangling Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Nitrile Examination Gloves - Non Sterile?

The FDA product code for Disposable Medical Nitrile Examination Gloves - Non Sterile 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.

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.

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.