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

FDA 510(k)

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

K-Number: K210774 · 2021-05-14

ApplicantShandong Jieshi Medical Products Co., Ltd.
Decision Date2021-05-14
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a medical device manufactured by Shandong Jieshi Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-05-14 under approval number K210774. 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 Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a medical device that received FDA 510(k) clearance on 2021-05-14. It is manufactured by Shandong Jieshi Medical Products Co., Ltd.. The 510(k) number is K210774.

When was Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) approved by the FDA?

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) received FDA 510(k) clearance on 2021-05-14, under approval number K210774.

What company makes Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is manufactured by Shandong Jieshi Medical Products Co., Ltd..

What is the FDA product code for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

The FDA product code for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is LYZ.

Related Clinical Trials

NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT07608406 Modified Versus Clear Twin Block for Skeletal Class II Malocclusion NOT_YET_RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT07193407 INOPASE - Performance and Safety Study of a Personalised SNM System RECRUITING NCT07589452 Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction NOT_YET_RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING

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)

Other Devices by Shandong Jieshi Medical Products Co., Ltd.

K210777Powder Free Nitrile Patient Examination Gloves, Blue Color

Related Devices (Code: LYZ)

K162259DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)Zibo Daiyang Plastic Company K161390Vinyl Exam Gloves, Powder Free, ClearZibo Hongchin Plastic and Rubber Co., Ltd. K160675Powder free vinyl patient examination glove, colored (yellow)Kaixing Plastic Products Co., Litd. K160411Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera CoatingCardinal Health, Inc. K161072Powder Free Grey Vinyl Examination GlovesZibo Flourish Trading Co., Ltd. K160468Synthetic Vinyl Examination Gloves, Powder-Free, YellowInpro Technology Device Factory

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.

↑