FDA.report

Product code KGO

Current FDA Classification

Device name
Surgeon'S Gloves
Medical specialty
General, Plastic Surgery
Device class
1
Regulation number
878.4460
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible
Definition
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.

Related 510(k) Records

510(k)DeviceApplicantDecision date
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
K222350Sterile Nitrile Surgical Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd.2023-04-13
K222620Sterilized Latex Surgical GlovesSuzhou Colour-Way New Material Co., Ltd.2023-03-23
K221424Sterile Surgical Powder Free Latex GloveNew Era Medicare Sdn. Bhd.2023-01-26
K222058Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl ResistantWrp Asia Pacific Sdn. Bhd.2022-10-22
K221718Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)Hartalega NGC Sdn. Bhd.2022-09-24
K221748Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical GlovesGuilin Hbm Health Protections, Inc.2022-09-13
K214074Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy DrugsHartalega NGC Sdn. Bhd.2022-05-26
K211953Disposable Sterilized Latex Surgical GlovesJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.2022-05-25
K212596Sterile Latex Surgical Gloves Powder FreeAmazing Rubber Products Pvt, Ltd.2022-03-01
K212848Sterile Latex Surgical Gloves Powder FreePentavest Holdings Sdn Bhd2021-12-27
K210969NulifeMrk Healthcare Pvt, Ltd.2021-11-03
K211621Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)Careplus (M) Sdn Bhd2021-10-06
K201592Cardinal Health Protexis PI Blue with Neu-Thera Surgical GloveCardinal Health200, LLC2021-09-26
K211478Sterile Latex Surgical Gloves Powder FreeAspen Glove Sdn. Bhd.2021-09-16
K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugsCareplus (M) Sdn Bhd2021-08-03
K203538SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)Medline Industries, Inc.2021-08-02

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