FDA.reportPublic FDA data

510(k) K250313

Device
Sterile Powder Free Synthetic Rubber Surgeon?s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
Applicant
Harps Europe Manufacturing GmbH
510(k) number
K250313
Product code
KGO
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-19
Date received
2025-02-03
Regulation
878.4460
Classification name
Surgeon'S Gloves
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
1
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alexander Weinert
Address
Triester Bundesstrasse 26 Wimpassing Niederosterreich Niederosterreich AT 2632 2632

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
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
K222350Sterile Nitrile Surgical Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd.2023-04-13