Single-Use Latex Sterile Surgical Gloves (SG100)

FDA 510(k) K231446 · Fitone Latex Products Co., Ltd. Guangdong

Substantially Equivalent

510(k) numberK231446

Submission

Device name
Single-Use Latex Sterile Surgical Gloves (SG100)
Applicant
Fitone Latex Products Co., Ltd. Guangdong
Zhanjiang, CN
Received
May 18, 2023
Decision date
September 22, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KGO – Surgeon'S Gloves
Device class
Class I (low risk)
Regulation
21 CFR 878.4460
Specialty
General, Plastic Surgery

A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Other 510(k)s with product code KGO

510(k)DeviceApplicantDecision
K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl…KGO · Traditional Hartalega NGC Sdn. Bhd.07/28/2026SE
K253060Sterile Latex Powder Free Surgical GlovesKGO · Traditional Protect Gloves Company Limited05/22/2026SE
K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With…KGO · Abbreviated Harps Europe Manufacturing GmbH08/19/2025SE
K240790Polyisoprene Surgical glovesKGO · Traditional Suzhou Colour-Way New Material Co., Ltd.08/23/2024SE
K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with…KGO · Traditional Wrp Asia Pacific Sdn. Bhd.03/28/2024SE
K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsKGO · Traditional Grand Work Plastic Products Co., Ltd.12/20/2023SE
K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid…KGO · Traditional Ansell Healthcare10/20/2023SE
K231973PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical GloveKGO · Traditional Ineo Tech Sdn Bhd09/29/2023SE
K230578Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with…KGO · Traditional Wrp Asia Pacific Sdn. Bhd.08/31/2023SE
K230079Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis…KGO · Traditional Ansell Healthcare Products, LLC08/23/2023SE

More from Ansell Healthcare Products, LLC

510(k)DeviceDecision
K221747Nitrile Patient Examination Gloves Tested For Use With Chemotherapy DrugsLZA · Traditional 12/01/2022SE
K222693Single-use medical latex examination gloves (LG100)LYY · Traditional 09/24/2022SE
K211927Nitrile examination glovesLZA · Traditional 10/12/2021SE

Questions and answers

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

Single-Use Latex Sterile Surgical Gloves (SG100) (K231446) received a 510(k) decision of Substantially Equivalent on September 22, 2023, 127 days after the submission was received.

What is the product code of K231446?

The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.