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FDA 510(k)

Clear Vinyl Powder-free Patient Examination Gloves

K-Number: K171317 · 2017-09-11

ApplicantShandong Zhi Hong Medical Products, Co. , Ltd.
Decision Date2017-09-11
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Clear Vinyl Powder-free Patient Examination Gloves is a medical device manufactured by Shandong Zhi Hong Medical Products, Co. , Ltd.. It received FDA 510(k) clearance on 2017-09-11 under approval number K171317. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clear Vinyl Powder-free Patient Examination Gloves?

Clear Vinyl Powder-free Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2017-09-11. It is manufactured by Shandong Zhi Hong Medical Products, Co. , Ltd.. The 510(k) number is K171317.

When was Clear Vinyl Powder-free Patient Examination Gloves approved by the FDA?

Clear Vinyl Powder-free Patient Examination Gloves received FDA 510(k) clearance on 2017-09-11, under approval number K171317.

What company makes Clear Vinyl Powder-free Patient Examination Gloves?

Clear Vinyl Powder-free Patient Examination Gloves is manufactured by Shandong Zhi Hong Medical Products, Co. , Ltd..

What is the FDA product code for Clear Vinyl Powder-free Patient Examination Gloves?

The FDA product code for Clear Vinyl Powder-free Patient Examination Gloves is LYZ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41533265 Modernizing Medical Software Regulation in Bangladesh: A Roadmap for Risk-Based SaMD Oversight. Journal of medical systems (2026) PMID: 41515650 Milestone to Ensure Safety and Efficacy of Companion Diagnostic (CDx) That Support Treatment Decisions in Cancer Patients. Diagnostics (Basel, Switzerland) (2026) PMID: 41484623 The need for clear medical data ownership laws. Journal of translational medicine (2026) PMID: 40976520 Reusing clinical trial data to consolidate and advance medical knowledge. Journal of clinical epidemiology (2025)

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Official Source

View on FDA Database →

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