FDA.reportPublic FDA data

510(k) K010438

Device
MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS)
Applicant
Terang Nusa Sdn Bhd
510(k) number
K010438
Product code
KGO
Decision
Substantially Equivalent (SESE)
Decision date
2001-05-01
Date received
2001-02-13
Regulation
878.4460
Classification name
Surgeon'S Gloves
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
CHIN-GUAN LOW
Address
1 Jalan 8, Pengkalan Chepa 2, Industrial Zone Kota Bharu MY 16100 16100

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KGO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company Limited2026-05-22
K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbH2025-08-19
K240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.2024-08-23
K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.2024-03-28
K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.2023-12-20
K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)Ansell Healthcare2023-10-20
K231973PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical GloveIneo Tech Sdn Bhd2023-09-29
K231446Single-Use Latex Sterile Surgical Gloves (SG100)Fitone Latex Products Co., Ltd. Guangdong2023-09-22
K230578Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.2023-08-31
K230079Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis PotentialAnsell Healthcare Products, LLC2023-08-23
K222993Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy DrugsSentienx Sdn Bhd2023-08-18
K230832Powdered Free Sterile Natural Rubber Latex Surgical GlovesThe Egyptian Company For Medical & Electronic Industries2023-08-16
K230304Polyisoprene Surgical GlovesPuyang Linshi Medical Supplies Co., Ltd.2023-08-09
K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsAnsell Healthcare Products, LLC2023-05-26
K230217Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.2023-05-13