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)

STERILE VINYL EXAMINATION GLOVES, Powder Free

K-Number: K170612 · 2017-10-23

ApplicantPrimus Gloves Pvt Limited
Decision Date2017-10-23
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE VINYL EXAMINATION GLOVES, Powder Free is a medical device manufactured by Primus Gloves Pvt Limited. It received FDA 510(k) clearance on 2017-10-23 under approval number K170612. 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 STERILE VINYL EXAMINATION GLOVES, Powder Free?

STERILE VINYL EXAMINATION GLOVES, Powder Free is a medical device that received FDA 510(k) clearance on 2017-10-23. It is manufactured by Primus Gloves Pvt Limited. The 510(k) number is K170612.

When was STERILE VINYL EXAMINATION GLOVES, Powder Free approved by the FDA?

STERILE VINYL EXAMINATION GLOVES, Powder Free received FDA 510(k) clearance on 2017-10-23, under approval number K170612.

What company makes STERILE VINYL EXAMINATION GLOVES, Powder Free?

STERILE VINYL EXAMINATION GLOVES, Powder Free is manufactured by Primus Gloves Pvt Limited.

What is the FDA product code for STERILE VINYL EXAMINATION GLOVES, Powder Free?

The FDA product code for STERILE VINYL EXAMINATION GLOVES, Powder Free is LYZ.

Related Clinical Trials

NCT06968845 A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis RECRUITING NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT06849856 Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches COMPLETED

Other Devices by Primus Gloves Pvt Limited

K143477Nitrile Patient Examination gloves, Powderfree, Blue color K170515Sterile Nitrile Surgical Gloves, Powder-free

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.

↑