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)

SensiCare PI Surgical Gloves

K-Number: K152428 · 2016-03-31

ApplicantMedline Industries, Inc.
Decision Date2016-03-31
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SensiCare PI Surgical Gloves is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2016-03-31 under approval number K152428. 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 SensiCare PI Surgical Gloves?

SensiCare PI Surgical Gloves is a medical device that received FDA 510(k) clearance on 2016-03-31. It is manufactured by Medline Industries, Inc.. The 510(k) number is K152428.

When was SensiCare PI Surgical Gloves approved by the FDA?

SensiCare PI Surgical Gloves received FDA 510(k) clearance on 2016-03-31, under approval number K152428.

What company makes SensiCare PI Surgical Gloves?

SensiCare PI Surgical Gloves is manufactured by Medline Industries, Inc..

What is the FDA product code for SensiCare PI Surgical Gloves?

The FDA product code for SensiCare PI Surgical Gloves is KGO.

Related Clinical Trials

NCT07372638 Sensorised Surgical Gloves for Neuroendovascular Procedures NOT_YET_RECRUITING

Other Devices by Medline Industries, Inc.

K162829Medline UNITE® Ankle Fracture Plating System K160642Medline ENFit Syringe K161473Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr) K152564Gemini Sterilization Wrap K161035Medline Singe Patient Use Blood Pressure Cuff K152458Gemini Bonded Sterilization Wrap

View all 75 devices →

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. K151778Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingCardinal Health 200, 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.

↑