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)

Polyisoprene Surgical Gloves

K-Number: K230304 · 2023-08-09

ApplicantPuyang Linshi Medical Supplies Co., Ltd.
Decision Date2023-08-09
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Polyisoprene Surgical Gloves is a medical device manufactured by Puyang Linshi Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2023-08-09 under approval number K230304. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Polyisoprene Surgical Gloves?

Polyisoprene Surgical Gloves is a medical device that received FDA 510(k) clearance on 2023-08-09. It is manufactured by Puyang Linshi Medical Supplies Co., Ltd.. The 510(k) number is K230304.

When was Polyisoprene Surgical Gloves approved by the FDA?

Polyisoprene Surgical Gloves received FDA 510(k) clearance on 2023-08-09, under approval number K230304.

What company makes Polyisoprene Surgical Gloves?

Polyisoprene Surgical Gloves is manufactured by Puyang Linshi Medical Supplies Co., Ltd..

What is the FDA product code for Polyisoprene Surgical Gloves?

The FDA product code for Polyisoprene Surgical Gloves is KGO.

Related Clinical Trials

NCT07372638 Sensorised Surgical Gloves for Neuroendovascular Procedures NOT_YET_RECRUITING

Related Devices (Code: KGO)

K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)Hartalega Sdb. Bhd. K160974Gammex Cut-Resistant Glove LinerAnsell Healthcare Products, LLC K161008POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVEHartalega Sdn Bhd K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingCardinal Health, Inc. K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)Cardinal Health, Inc. K152428SensiCare PI Surgical GlovesMedline Industries, Inc.

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.

↑