ClearanceBrief
Panels › General, Plastic Surgery › Product code KGO · Class 1

Surgeon'S Gloves

Regulation 878.4460

2510(k)s in 12 months (560 all time)
1recalls in 12 months (44 all time)
43recalls that name a 510(k)
Get daily alerts for KGOSample briefCSV

Top companies in KGO

Company510(k)sRecalls
Ansell Healthcare Products, Inc.1612
Cardinal Health, Inc.138
Wrp Asia Pacific Sdn. Bhd.201
Cardinal Health 200, Inc.117
Terang Nusa Sdn Bhd152
Molnlycke Health Care Us, LLC160
Ansell Perry150
Wembley Rubber Products (M) Sdn Bhd150
Medline Industries, Inc.122
Johnson & Johnson Medical, Inc.100
Decided510(k)Device and applicantCode
Jul 28, 2026K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgica
Hartalega NGC Sdn. Bhd., MY
KGO
May 22, 2026K253060Sterile Latex Powder Free Surgical Gloves
Protect Gloves Company Limited, TH
KGO
Aug 19, 2025K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric A
Harps Europe Manufacturing GmbH, AT
KGO
Aug 23, 2024K240790Polyisoprene Surgical gloves
Suzhou Colour-Way New Material Co., Ltd., CN
KGO
Mar 28, 2024K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green);
Wrp Asia Pacific Sdn. Bhd., MY
KGO
Dec 20, 2023K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
Grand Work Plastic Products Co., Ltd., CN
KGO
Oct 20, 2023K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hy
Ansell Healthcare
KGO
Sep 29, 2023K231973PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
Ineo Tech Sdn Bhd, MY
KGO
Sep 22, 2023K231446Single-Use Latex Sterile Surgical Gloves (SG100)
Fitone Latex Products Co., Ltd. Guangdong, CN
KGO
Aug 31, 2023K230578Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
Wrp Asia Pacific Sdn. Bhd., MY
KGO
Aug 23, 2023K230079Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential
Ansell Healthcare Products, LLC
KGO
Aug 18, 2023K222993Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drug
Sentienx Sdn Bhd, MY
KGO
Aug 16, 2023K230832Powdered Free Sterile Natural Rubber Latex Surgical Gloves
The Egyptian Company For Medical & Electronic Industries, EG
KGO
Aug 9, 2023K230304Polyisoprene Surgical Gloves
Puyang Linshi Medical Supplies Co., Ltd., CN
KGO
May 26, 2023K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
Ansell Healthcare Products, LLC
KGO
May 13, 2023K230217Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
Grand Work Plastic Products Co., Ltd., CN
KGO
Apr 13, 2023K222350Sterile Nitrile Surgical Gloves Powder Free
Jr Engineering & Medical Technologies (M) Sdn. Bhd., MY
KGO
Mar 23, 2023K222620Sterilized Latex Surgical Gloves
Suzhou Colour-Way New Material Co., Ltd., CN
KGO
Jan 26, 2023K221424Sterile Surgical Powder Free Latex Glove
New Era Medicare Sdn. Bhd., MY
KGO
Oct 22, 2022K222058Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
Wrp Asia Pacific Sdn. Bhd., MY
KGO
Sep 24, 2022K221718Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
Hartalega NGC Sdn. Bhd., MY
KGO
Sep 13, 2022K221748Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
Guilin Hbm Health Protections, Inc., CN
KGO
May 26, 2022K214074Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Us
Hartalega NGC Sdn. Bhd., MY
KGO
May 25, 2022K211953Disposable Sterilized Latex Surgical Gloves
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd., CN
KGO
Mar 1, 2022K212596Sterile Latex Surgical Gloves Powder Free
Amazing Rubber Products Pvt, Ltd., IN
KGO
Dec 27, 2021K212848Sterile Latex Surgical Gloves Powder Free
Pentavest Holdings Sdn Bhd, MY
KGO
Nov 3, 2021K210969Nulife
Mrk Healthcare Pvt, Ltd., IN
KGO
Oct 6, 2021K211621Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)
Careplus (M) Sdn Bhd, MY
KGO
Sep 26, 2021K201592Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
Cardinal Health200, LLC
KGO
Sep 16, 2021K211478Sterile Latex Surgical Gloves Powder Free
Aspen Glove Sdn. Bhd., MY
KGO
Aug 3, 2021K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of tota
Careplus (M) Sdn Bhd, MY
KGO
Aug 2, 2021K203538SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)
Medline Industries, Inc.
KGO
Jul 9, 2021K200915Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs
Gx Corporation Sdn Bhd, MY
KGO
Jun 24, 2021K210656ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total
Careplus (M) Sdn Bhd, MY
KGO
Jun 11, 2021K203030POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Wrp Asia Pacific Sdn. Bhd., MY
KGO
May 27, 2021K202765ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Teste
Careplus (M) Sdn Bhd, MY
KGO
Feb 17, 2021K202401Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extrac
Eco Medi Glove Sdn. Bhd., MY
KGO
Feb 1, 2021K203483Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
Guilin Hbm Health Protections, Inc., CN
KGO
Jan 13, 2021K192933Polyisoprene Powder Free, Black Colour Surgical Gloves
Emerson & Co. Srl, IT
KGO
Dec 19, 2020K202668Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Pr
Medline Industries, Inc.
KGO
Nov 22, 2020K202090Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Ind
Molnlycke Health Care Us, LLC
KGO
Nov 18, 2020K202449Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Cla
Medline Industries, Inc.
KGO
Oct 2, 2020K201748Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for u
Hartalega Sdn Bhd, MY
KGO
Sep 16, 2020K201774Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs
Pt. Medisafe Technologies, ID
KGO
Sep 9, 2020K201829SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)
Medline Industries, Inc.
KGO
Jun 1, 2020K200897Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical G
Hartalega Sdn Bhd, MY
KGO
Apr 10, 2020K193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
Molnlycke Health Care Us, LLC
KGO
Apr 6, 2020K193217SensiCare PI and SensiCare PI Micro Surgical Gloves
Medline Industries, Inc.
KGO
Apr 1, 2020K192988Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use
Medline Industries, Inc.
KGO
Mar 31, 2020K191860Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential
Semperit Technische Produkte Gesellchaft M.B.H., AT
KGO

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.