Powder-Free Clear Vinyl Patient Examination Gloves
K-Number: K190095 · 2019-06-20
Decision Date2019-06-20
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Powder-Free Clear Vinyl Patient Examination Gloves is a medical device manufactured by Anhui Intco Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2019-06-20 under approval number K190095. 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 Clear Vinyl Patient Examination Gloves?
Powder-Free Clear Vinyl Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2019-06-20. It is manufactured by Anhui Intco Medical Products Co., Ltd.. The 510(k) number is K190095.
When was Powder-Free Clear Vinyl Patient Examination Gloves approved by the FDA?
Powder-Free Clear Vinyl Patient Examination Gloves received FDA 510(k) clearance on 2019-06-20, under approval number K190095.
What company makes Powder-Free Clear Vinyl Patient Examination Gloves?
Powder-Free Clear Vinyl Patient Examination Gloves is manufactured by Anhui Intco Medical Products Co., Ltd..
What is the FDA product code for Powder-Free Clear Vinyl Patient Examination Gloves?
The FDA product code for Powder-Free Clear Vinyl Patient Examination Gloves 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 Anhui Intco Medical Products Co., Ltd.
K191092Powder-Free Vinyl Patient Examination Gloves, Yellow Color
K231365Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves
K233598Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
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.