FDA Product Code
FDA Product Code KGO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4460
510(k) Clearances — 560 records · page 1 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Hartalega NGC Sdn. Bhd. | 2026-07-28 | Traditional | PDF ↗ |
| K253060 | Sterile Latex Powder Free Surgical Gloves | Protect Gloves Company Limited | 2026-05-22 | Traditional | PDF ↗ |
| K250313 | Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid | Harps Europe Manufacturing GmbH | 2025-08-19 | Abbreviated | PDF ↗ |
| K240790 | Polyisoprene Surgical gloves | Suzhou Colour-Way New Material Co., Ltd. | 2024-08-23 | Traditional | PDF ↗ |
| K232079 | Natural 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 Fentanyl | Wrp Asia Pacific Sdn. Bhd. | 2024-03-28 | Traditional | PDF ↗ |
| K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | 2023-12-20 | Traditional | PDF ↗ |
| K231902 | GAMMEX 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 Healthcare | 2023-10-20 | Traditional | PDF ↗ |
| K231973 | PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove | Ineo Tech Sdn Bhd | 2023-09-29 | Traditional | PDF ↗ |
| K231446 | Single-Use Latex Sterile Surgical Gloves (SG100) | Fitone Latex Products Co., Ltd. Guangdong | 2023-09-22 | Traditional | PDF ↗ |
| K230578 | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | Wrp Asia Pacific Sdn. Bhd. | 2023-08-31 | Traditional | PDF ↗ |
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential | Ansell Healthcare Products, LLC | 2023-08-23 | Traditional | PDF ↗ |
| K222993 | Flexylon 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 Drugs | Sentienx Sdn Bhd | 2023-08-18 | Traditional | PDF ↗ |
| K230832 | Powdered Free Sterile Natural Rubber Latex Surgical Gloves | The Egyptian Company For Medical & Electronic Industries | 2023-08-16 | Traditional | PDF ↗ |
| K230304 | Polyisoprene Surgical Gloves | Puyang Linshi Medical Supplies Co., Ltd. | 2023-08-09 | Traditional | PDF ↗ |
| K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | 2023-05-26 | Traditional | PDF ↗ |
| K230217 | Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | 2023-05-13 | Traditional | PDF ↗ |
| K222350 | Sterile Nitrile Surgical Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2023-04-13 | Abbreviated | PDF ↗ |
| K222620 | Sterilized Latex Surgical Gloves | Suzhou Colour-Way New Material Co., Ltd. | 2023-03-23 | Traditional | PDF ↗ |
| K221424 | Sterile Surgical Powder Free Latex Glove | New Era Medicare Sdn. Bhd. | 2023-01-26 | Traditional | PDF ↗ |
| K222058 | Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant | Wrp Asia Pacific Sdn. Bhd. | 2022-10-22 | Traditional | PDF ↗ |
| K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) | Hartalega NGC Sdn. Bhd. | 2022-09-24 | Traditional | PDF ↗ |
| K221748 | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves | Guilin Hbm Health Protections, Inc. | 2022-09-13 | Traditional | PDF ↗ |
| K214074 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs | Hartalega NGC Sdn. Bhd. | 2022-05-26 | Traditional | PDF ↗ |
| K211953 | Disposable Sterilized Latex Surgical Gloves | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | 2022-05-25 | Traditional | PDF ↗ |
| K212596 | Sterile Latex Surgical Gloves Powder Free | Amazing Rubber Products Pvt, Ltd. | 2022-03-01 | Abbreviated | PDF ↗ |
| K212848 | Sterile Latex Surgical Gloves Powder Free | Pentavest Holdings Sdn Bhd | 2021-12-27 | Abbreviated | PDF ↗ |
| K210969 | Nulife | Mrk Healthcare Pvt, Ltd. | 2021-11-03 | Abbreviated | PDF ↗ |
| K211621 | Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) | Careplus (M) Sdn Bhd | 2021-10-06 | Traditional | PDF ↗ |
| K201592 | Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove | Cardinal Health200, LLC | 2021-09-26 | Traditional | PDF ↗ |
| K211478 | Sterile Latex Surgical Gloves Powder Free | Aspen Glove Sdn. Bhd. | 2021-09-16 | Abbreviated | PDF ↗ |
| K210724 | ENCORE 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 drugs | Careplus (M) Sdn Bhd | 2021-08-03 | Traditional | PDF ↗ |
| K203538 | SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) | Medline Industries, Inc. | 2021-08-02 | Traditional | PDF ↗ |
| K200915 | Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs | Gx Corporation Sdn Bhd | 2021-07-09 | Traditional | PDF ↗ |
| K210656 | ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs | Careplus (M) Sdn Bhd | 2021-06-24 | Traditional | PDF ↗ |
| K203030 | POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Wrp Asia Pacific Sdn. Bhd. | 2021-06-11 | Traditional | PDF ↗ |
| K202765 | ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs | Careplus (M) Sdn Bhd | 2021-05-27 | Traditional | PDF ↗ |
| K202401 | Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein | Eco Medi Glove Sdn. Bhd. | 2021-02-17 | Traditional | PDF ↗ |
| K203483 | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves | Guilin Hbm Health Protections, Inc. | 2021-02-01 | Traditional | PDF ↗ |
| K192933 | Polyisoprene Powder Free, Black Colour Surgical Gloves | Emerson & Co. Srl | 2021-01-13 | Special | PDF ↗ |
| K202668 | Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein | Medline Industries, Inc. | 2020-12-19 | Traditional | PDF ↗ |
| K202090 | Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim | Molnlycke Health Care Us, LLC | 2020-11-22 | Traditional | PDF ↗ |
| K202449 | Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein | Medline Industries, Inc. | 2020-11-18 | Traditional | PDF ↗ |
| K201748 | Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs | Hartalega Sdn Bhd | 2020-10-02 | Traditional | PDF ↗ |
| K201774 | Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs | Pt. Medisafe Technologies | 2020-09-16 | Traditional | PDF ↗ |
| K201829 | SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) | Medline Industries, Inc. | 2020-09-09 | Traditional | PDF ↗ |
| K200897 | Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) | Hartalega Sdn Bhd | 2020-06-01 | Traditional | PDF ↗ |
| K193573 | Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro | Molnlycke Health Care Us, LLC | 2020-04-10 | Traditional | PDF ↗ |
| K193217 | SensiCare PI and SensiCare PI Micro Surgical Gloves | Medline Industries, Inc. | 2020-04-06 | Traditional | PDF ↗ |
| K192988 | Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use | Medline Industries, Inc. | 2020-04-01 | Traditional | PDF ↗ |
| K191860 | Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis Potential | Semperit Technische Produkte Gesellchaft M.B.H. | 2020-03-31 | Abbreviated | PDF ↗ |
| K191869 | Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim | Molnlycke Health Care Us, LLC | 2020-03-13 | Traditional | PDF ↗ |
| K192328 | JR.MEDIK Latex Surgeons Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2020-03-10 | Abbreviated | PDF ↗ |
| K191915 | SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V | Medline Industries, Inc. | 2020-03-06 | Traditional | PDF ↗ |
| K192820 | SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) | Medline Industries, Inc. | 2020-02-28 | Traditional | PDF ↗ |
| K190241 | Sterile Latex Surgical Glove, Powder Free | Careglove Global Sdn. Bhd. | 2019-12-30 | Traditional | PDF ↗ |
| K191898 | Sterile Latex Powder-Free Surgical Gloves | Modern Healthcare Corp. | 2019-12-18 | Traditional | PDF ↗ |
| K190632 | Latex Surgeons Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein | Lenora Glove Pvt , Ltd. | 2019-10-24 | Abbreviated | PDF ↗ |
| K183536 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove | Hartalega NGC Sdn. Bhd. | 2019-08-16 | Traditional | PDF ↗ |
| K183389 | Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove | Hartalega NGC Sdn. Bhd. | 2019-06-28 | Traditional | PDF ↗ |
| K190782 | FlexGard Cut-Resistant Glove Liners | Ldi Corporation | 2019-06-27 | Abbreviated | PDF ↗ |
| K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove | Molnlycke Health Care Us, LLC | 2019-05-24 | Traditional | PDF ↗ |
| K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | 2019-05-23 | Traditional | PDF ↗ |
| K182176 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs | Pt. Medisafe Technologies | 2019-03-28 | Traditional | PDF ↗ |
| K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | 2019-03-22 | Traditional | PDF ↗ |
| K181047 | Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs | Smart Glove Corporation Sdn. Bhd. | 2019-01-09 | Traditional | PDF ↗ |
| K180221 | Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs | Smart Glove Corporation Sdn. Bhd. | 2018-08-08 | Traditional | PDF ↗ |
| K171550 | Sterile Latex Surgical Gloves, Powder Free | Sanrea Healthcare Products Pvt, Ltd. | 2018-07-13 | Traditional | PDF ↗ |
| K173304 | Finessis Intense Polyisoprene Surgical Glove | Lucenxia Prescience AG | 2018-04-30 | Special | PDF ↗ |
| K173258 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy | Pt. Medisafe Technologies | 2018-04-20 | Traditional | PDF ↗ |
| K173386 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs | Lucenxia Prescience AG | 2018-04-09 | Traditional | PDF ↗ |
| K171375 | Gammex PI Breach Detect Powder Free Surgical Glove | Ansell Healthcare Products, LLC | 2018-02-06 | Traditional | PDF ↗ |
| K172942 | Pristeen (Latex Surgeons Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein | Beta Healthcare Products Pvt., Ltd. | 2018-01-08 | Abbreviated | PDF ↗ |
| K171987 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove | Lucenxia Prescience AG | 2017-10-20 | Special | PDF ↗ |
| K171279 | Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves | Top Glove Sdn. Bhd. | 2017-10-12 | Traditional | PDF ↗ |
| K172420 | Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim | Wear Safe (Malaysia) Sdn. Bhd. | 2017-09-29 | Traditional | PDF ↗ |
| K171276 | Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs | Tg Medical Sdn. Bhd. | 2017-08-21 | Traditional | PDF ↗ |
| K171898 | Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs | Better Care Plastic Technology Co., Ltd. | 2017-08-18 | Traditional | PDF ↗ |
| K171047 | Sterile Polyisoprene Powder Free Surgical Gloves | Better Care Plastic Technology Co., Ltd. | 2017-06-22 | Traditional | PDF ↗ |
| K170198 | Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) | Cardinal Health, Inc. | 2017-06-15 | Traditional | PDF ↗ |
| K170515 | Sterile Nitrile Surgical Gloves, Powder-free | Primus Gloves Pvt Limited | 2017-06-09 | Traditional | PDF ↗ |
| K170152 | POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) | Hartalega Sdn Bhd | 2017-05-05 | Traditional | PDF ↗ |
| K160781 | Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves | Semperit Investments Asia Pte , Ltd. | 2017-05-02 | Abbreviated | PDF ↗ |
| K162852 | Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove | Lucenxia Prescience AG | 2017-02-08 | Traditional | PDF ↗ |
| K161823 | Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs | Wrp Asia Pacific Sdn. Bhd. | 2017-01-23 | Traditional | PDF ↗ |
| K160928 | Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green) | Hartalega Sdb. Bhd. | 2016-12-20 | Traditional | PDF ↗ |
| K160974 | Gammex Cut-Resistant Glove Liner | Ansell Healthcare Products, LLC | 2016-10-28 | Traditional | PDF ↗ |
| K161008 | POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE | Hartalega Sdn Bhd | 2016-07-28 | Traditional | PDF ↗ |
| K160875 | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | Cardinal Health, Inc. | 2016-07-11 | Traditional | PDF ↗ |
| K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) | Cardinal Health, Inc. | 2016-05-12 | Traditional | PDF ↗ |
| K152428 | SensiCare PI Surgical Gloves | Medline Industries, Inc. | 2016-03-31 | Traditional | PDF ↗ |
| K151778 | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | Cardinal Health 200, Inc. | 2016-03-24 | Traditional | PDF ↗ |
| K151694 | Gammex PI Hybrid Surgical Gloves | Ansell Healthcare Products, LLC | 2016-03-09 | Traditional | PDF ↗ |
| K151228 | PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm | Emerson & Co. Srl | 2016-01-15 | Traditional | PDF ↗ |
| K151114 | Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein | St. Marys Rubbers Pvt, Ltd. | 2015-12-11 | Abbreviated | PDF ↗ |
| K150238 | SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color | Medline Industries, Inc. | 2015-11-27 | Traditional | PDF ↗ |
| K151607 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove | Lucenxia Prescience AG | 2015-11-16 | Traditional | PDF ↗ |
| K151605 | Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves | Lucenxia Prescience AG | 2015-11-16 | Traditional | PDF ↗ |
| K150609 | Annuy Latex Surgeon's Gloves (Powdered and Powder Free) | Anhui Anyu Latex Products Co., Ltd. | 2015-11-16 | Traditional | PDF ↗ |
| K142941 | Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. | Pt. Medisafe Technologies | 2015-11-02 | Traditional | PDF ↗ |
| K151392 | Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less | Terang Nusa Sdn Bhd | 2015-09-18 | Traditional | PDF ↗ |
Product code KGO · Class I · General, Plastic Surgery. Data: openFDA.