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FDA 510(k)

Single-Use Latex Sterile Surgical Gloves (SG100)

K-Number: K231446 · 2023-09-22

ApplicantFitone Latex Products Co., Ltd. Guangdong
Decision Date2023-09-22
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Single-Use Latex Sterile Surgical Gloves (SG100) is a medical device manufactured by Fitone Latex Products Co., Ltd. Guangdong. It received FDA 510(k) clearance on 2023-09-22 under approval number K231446. 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 Single-Use Latex Sterile Surgical Gloves (SG100)?

Single-Use Latex Sterile Surgical Gloves (SG100) is a medical device that received FDA 510(k) clearance on 2023-09-22. It is manufactured by Fitone Latex Products Co., Ltd. Guangdong. The 510(k) number is K231446.

When was Single-Use Latex Sterile Surgical Gloves (SG100) approved by the FDA?

Single-Use Latex Sterile Surgical Gloves (SG100) received FDA 510(k) clearance on 2023-09-22, under approval number K231446.

What company makes Single-Use Latex Sterile Surgical Gloves (SG100)?

Single-Use Latex Sterile Surgical Gloves (SG100) is manufactured by Fitone Latex Products Co., Ltd. Guangdong.

What is the FDA product code for Single-Use Latex Sterile Surgical Gloves (SG100)?

The FDA product code for Single-Use Latex Sterile Surgical Gloves (SG100) is KGO.

Related Clinical Trials

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Fitone Latex Products Co., Ltd. Guangdong

K211927Nitrile examination gloves K221747Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs K222693Single-use medical latex examination gloves (LG100)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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