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)

Xingyu Nitrile Powder Free Patient Examination Gloves, White color

K-Number: K171615 · 2017-07-31

Decision Date2017-07-31
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Xingyu Nitrile Powder Free Patient Examination Gloves, White color is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Xingyu Gloves Co., Ltd.. It received FDA 510(k) clearance on 2017-07-31 under 510(k) number K171615. 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 Xingyu Nitrile Powder Free Patient Examination Gloves, White color?

Xingyu Nitrile Powder Free Patient Examination Gloves, White color is a medical device that received FDA 510(k) clearance on 2017-07-31. The listed applicant is Shandong Xingyu Gloves Co., Ltd.. The 510(k) number is K171615.

When did Xingyu Nitrile Powder Free Patient Examination Gloves, White color receive FDA 510(k) clearance?

Xingyu Nitrile Powder Free Patient Examination Gloves, White color received FDA 510(k) clearance on 2017-07-31, under 510(k) number K171615.

Who is the listed applicant for Xingyu Nitrile Powder Free Patient Examination Gloves, White color?

The FDA 510(k) record lists Shandong Xingyu Gloves Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xingyu Nitrile Powder Free Patient Examination Gloves, White color?

The FDA product code for Xingyu Nitrile Powder Free Patient Examination Gloves, White color is LZA.

Other records listing Shandong Xingyu Gloves 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.

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.