Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4460](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4460) → KGO — Surgeon'S Gloves # KGO · Surgeon'S Gloves _General, Plastic Surgery · 21 CFR 878.4460 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO ## Overview - **Product Code:** KGO - **Device Name:** Surgeon'S Gloves - **Regulation:** [21 CFR 878.4460](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4460) - **Device Class:** 1 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **3rd-party reviewable:** yes ## Identification A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing. ## Classification Rationale Class I (general controls). ## Recent Cleared Devices (20 of 558) Showing 20 most recent of 558 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250313](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K250313.md) | Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid | Harps Europe Manufacturing GmbH | Aug 19, 2025 | SESE | | [K240790](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K240790.md) | Polyisoprene Surgical gloves | Suzhou Colour-Way New Material Co., Ltd. | Aug 23, 2024 | SESE | | [K232079](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K232079.md) | 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. | Mar 28, 2024 | SESE | | [K232444](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K232444.md) | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | Dec 20, 2023 | SESE | | [K231902](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K231902.md) | 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 | Oct 20, 2023 | SESE | | [K231973](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K231973.md) | PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove | Ineo Tech Sdn Bhd | Sep 29, 2023 | SESE | | [K231446](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K231446.md) | Single-Use Latex Sterile Surgical Gloves (SG100) | Fitone Latex Products Co., Ltd. Guangdong | Sep 22, 2023 | SESE | | [K230578](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K230578.md) | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | Wrp Asia Pacific Sdn. Bhd. | Aug 31, 2023 | SESE | | [K230079](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K230079.md) | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential | Ansell Healthcare Products, LLC | Aug 23, 2023 | SESE | | [K222993](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K222993.md) | 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 | Aug 18, 2023 | SESE | | [K230832](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K230832.md) | Powdered Free Sterile Natural Rubber Latex Surgical Gloves | The Egyptian Company For Medical & Electronic Industries | Aug 16, 2023 | SESE | | [K230304](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K230304.md) | Polyisoprene Surgical Gloves | Puyang Linshi Medical Supplies Co., Ltd. | Aug 9, 2023 | SESE | | [K213289](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K213289.md) | Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | May 26, 2023 | SESE | | [K230217](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K230217.md) | Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | May 13, 2023 | SESE | | [K222350](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K222350.md) | Sterile Nitrile Surgical Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | Apr 13, 2023 | SESE | | [K222620](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K222620.md) | Sterilized Latex Surgical Gloves | Suzhou Colour-Way New Material Co., Ltd. | Mar 23, 2023 | SESE | | [K221424](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K221424.md) | Sterile Surgical Powder Free Latex Glove | New Era Medicare Sdn. Bhd. | Jan 26, 2023 | SESE | | [K222058](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K222058.md) | Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant | Wrp Asia Pacific Sdn. Bhd. | Oct 22, 2022 | SESE | | [K221718](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K221718.md) | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) | Hartalega NGC Sdn. Bhd. | Sep 24, 2022 | SESE | | [K221748](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO/K221748.md) | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves | Guilin Hbm Health Protections, Inc. | Sep 13, 2022 | SESE | ## Top Applicants - Wrp Asia Pacific Sdn. Bhd. — 20 clearances - Molnlycke Health Care Us, LLC — 16 clearances - Wembley Rubber Products (M) Sdn Bhd — 15 clearances - Terang Nusa Sdn Bhd — 15 clearances - Ansell Perry — 15 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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