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 Latex Surgical Glove, Powder Free

K-Number: K190241 · 2019-12-30

ApplicantCareglove Global Sdn. Bhd.
Decision Date2019-12-30
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Latex Surgical Glove, Powder Free is a medical device manufactured by Careglove Global Sdn. Bhd.. It received FDA 510(k) clearance on 2019-12-30 under approval number K190241. 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 Sterile Latex Surgical Glove, Powder Free?

Sterile Latex Surgical Glove, Powder Free is a medical device that received FDA 510(k) clearance on 2019-12-30. It is manufactured by Careglove Global Sdn. Bhd.. The 510(k) number is K190241.

When was Sterile Latex Surgical Glove, Powder Free approved by the FDA?

Sterile Latex Surgical Glove, Powder Free received FDA 510(k) clearance on 2019-12-30, under approval number K190241.

What company makes Sterile Latex Surgical Glove, Powder Free?

Sterile Latex Surgical Glove, Powder Free is manufactured by Careglove Global Sdn. Bhd..

What is the FDA product code for Sterile Latex Surgical Glove, Powder Free?

The FDA product code for Sterile Latex Surgical Glove, Powder Free is KGO.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_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 NCT07529444 Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants RECRUITING NCT06849856 Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches COMPLETED

Other Devices by Careglove Global Sdn. Bhd.

K172015POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) K161833LATEX EXAMINATION GLOVE POWDER FREE K220859Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) K213993Powder Free Chloroprene Examination Glove Coloured (Blue, Green) K211666Powder Free Nitrile Examination Gloves, Blue Chemotest K230121Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)

View all 8 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. 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.

↑