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510(k) K013603

Device
MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65
Applicant
Ansell Healthcare Products, Inc.
510(k) number
K013603
Product code
KGO
Decision
Substantially Equivalent (SESE)
Decision date
2001-11-13
Date received
2001-10-31
Regulation
878.4460
Classification name
Surgeon'S Gloves
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
JAMES R CHATTERTON
Address
1875 Harsh Ave. SE Massillon OH US 44646 44646

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
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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