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 Powder Free, Black Colour Surgical Gloves

K-Number: K192933 · 2021-01-13

ApplicantEmerson & Co. Srl
Decision Date2021-01-13
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Polyisoprene Powder Free, Black Colour Surgical Gloves is a medical device manufactured by Emerson & Co. Srl. It received FDA 510(k) clearance on 2021-01-13 under approval number K192933. 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 Powder Free, Black Colour Surgical Gloves?

Polyisoprene Powder Free, Black Colour Surgical Gloves is a medical device that received FDA 510(k) clearance on 2021-01-13. It is manufactured by Emerson & Co. Srl. The 510(k) number is K192933.

When was Polyisoprene Powder Free, Black Colour Surgical Gloves approved by the FDA?

Polyisoprene Powder Free, Black Colour Surgical Gloves received FDA 510(k) clearance on 2021-01-13, under approval number K192933.

What company makes Polyisoprene Powder Free, Black Colour Surgical Gloves?

Polyisoprene Powder Free, Black Colour Surgical Gloves is manufactured by Emerson & Co. Srl.

What is the FDA product code for Polyisoprene Powder Free, Black Colour Surgical Gloves?

The FDA product code for Polyisoprene Powder Free, Black Colour Surgical Gloves is KGO.

Related Clinical Trials

NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING NCT07372638 Sensorised Surgical Gloves for Neuroendovascular Procedures NOT_YET_RECRUITING NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED NCT05989750 Air-polishing With Erythritol During Orthodontic Tretament RECRUITING NCT06849856 Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches COMPLETED

Other Devices by Emerson & Co. Srl

K151228PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm

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.

↑