Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6250](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6250) → LYZ — Vinyl Patient Examination Glove # LYZ · Vinyl Patient Examination Glove _General Hospital · 21 CFR 880.6250 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ ## Overview - **Product Code:** LYZ - **Device Name:** Vinyl Patient Examination Glove - **Regulation:** [21 CFR 880.6250](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6250) - **Device Class:** 1 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## Identification A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. ## Recent Cleared Devices (20 of 799) Showing 20 most recent of 799 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260860](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K260860.md) | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | Basic Medical Technology, Inc. | Apr 7, 2026 | SESE | | [K252467](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K252467.md) | Disposable Vinyl Examination Gloves | Viet Phu Trade and Import Export Co., Ltd. | Oct 27, 2025 | SESE | | [K252505](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K252505.md) | Powder-Free Vinyl Exam Gloves, clear | Basic Medical Technology, Inc. | Aug 28, 2025 | SESE | | [K241252](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K241252.md) | Disposable Vinyl Examination Gloves | Anqing Pukang Medical Technology Co., Ltd. | May 20, 2024 | SESE | | [K230046](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K230046.md) | Vinyl examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | Mar 25, 2023 | SESE | | [K221980](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K221980.md) | Disposable Powder Free Vinyl Examination Gloves, Beige/Clear | Ever Global (Vietnam) Enterprise Corporation | Feb 6, 2023 | SESE | | [K220992](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K220992.md) | Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple | Ever Global (Vietnam) Enterprise Corporation | Oct 19, 2022 | SESE | | [K223008](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K223008.md) | Disposable Vinyl Examination Gloves | Jiangxi Handspro Products Solutions Co., Ltd. | Oct 8, 2022 | SESE | | [K222442](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K222442.md) | DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) | Anhui Bytech Medical Supplies Co., Ltd. | Sep 28, 2022 | SESE | | [K220055](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K220055.md) | Disposable, vinyl examination gloves, Yellow | Dezhou Hengchang Medical Technology Co., Ltd. | Aug 25, 2022 | SESE | | [K220469](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K220469.md) | Disposable Vinyl Examination Glove | Chifeng Huawei Medical Science&Technology Co., Ltd. | Jun 16, 2022 | SESE | | [K220240](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K220240.md) | Vinyl Co-Polymer Powder-free Examination Gloves, Black | Grand Work Plastic Products Co., Ltd. | Mar 31, 2022 | SESE | | [K213634](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K213634.md) | Vinyl/Nitrile Blend Exam Glove | Dezhou Hengchang Medical Technology Co., Ltd. | Feb 18, 2022 | SESE | | [K213625](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K213625.md) | Vinyl Examination Gloves | Dezhou Hengchang Medical Technology Co., Ltd. | Feb 17, 2022 | SESE | | [K212011](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K212011.md) | Vinyl Powder Free Examination Glove | Top Glove Vietnam Company Limited | Feb 14, 2022 | SESE | | [K213019](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K213019.md) | Vinyl Exam Gloves | Hebei Astro Medical Supply Co., Ltd. | Jan 5, 2022 | SESE | | [K212436](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K212436.md) | NBR Synthetic Nitrile Examination Gloves | Shandong Langtai International Trade Co., Ltd. | Dec 23, 2021 | SESE | | [K213144](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K213144.md) | Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors | Shen Wei USA, Inc. | Dec 22, 2021 | SESE | | [K213006](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K213006.md) | Vinyl Examination Gloves | Taian Hengchang Medical Technology Co., Ltd. | Dec 21, 2021 | SESE | | [K211865](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K211865.md) | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Liao Ning Shangwei Medical Products Co., Ltd. | Dec 20, 2021 | SESE | ## Top Applicants - Shanghai Antares Industries, Inc. — 14 clearances - Bd Becton Dickinson Vacutainer Systems Preanalytic — 13 clearances - Ever Light Plastic Products Co., Ltd. — 11 clearances - Grand Work Plastic Products Co., Ltd. — 11 clearances - Shanghai Palomar Mountain Industries, Inc. — 10 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ) **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. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com