LYZ · Vinyl Patient Examination Glove
General Hospital · 21 CFR 880.6250 · Class 1
Overview
| Product Code | LYZ |
|---|---|
| Device Name | Vinyl Patient Examination Glove |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| 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 | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | Basic Medical Technology, Inc. | Apr 7, 2026 | SESE |
| K252467 | Disposable Vinyl Examination Gloves | Viet Phu Trade and Import Export Co., Ltd. | Oct 27, 2025 | SESE |
| K252505 | Powder-Free Vinyl Exam Gloves, clear | Basic Medical Technology, Inc. | Aug 28, 2025 | SESE |
| K241252 | Disposable Vinyl Examination Gloves | Anqing Pukang Medical Technology Co., Ltd. | May 20, 2024 | SESE |
| K230046 | Vinyl examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | Mar 25, 2023 | SESE |
| K221980 | Disposable Powder Free Vinyl Examination Gloves, Beige/Clear | Ever Global (Vietnam) Enterprise Corporation | Feb 6, 2023 | SESE |
| K220992 | Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple | Ever Global (Vietnam) Enterprise Corporation | Oct 19, 2022 | SESE |
| K223008 | Disposable Vinyl Examination Gloves | Jiangxi Handspro Products Solutions Co., Ltd. | Oct 8, 2022 | SESE |
| K222442 | DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) | Anhui Bytech Medical Supplies Co., Ltd. | Sep 28, 2022 | SESE |
| K220055 | Disposable, vinyl examination gloves, Yellow | Dezhou Hengchang Medical Technology Co., Ltd. | Aug 25, 2022 | SESE |
| K220469 | Disposable Vinyl Examination Glove | Chifeng Huawei Medical Science&Technology Co., Ltd. | Jun 16, 2022 | SESE |
| K220240 | Vinyl Co-Polymer Powder-free Examination Gloves, Black | Grand Work Plastic Products Co., Ltd. | Mar 31, 2022 | SESE |
| K213634 | Vinyl/Nitrile Blend Exam Glove | Dezhou Hengchang Medical Technology Co., Ltd. | Feb 18, 2022 | SESE |
| K213625 | Vinyl Examination Gloves | Dezhou Hengchang Medical Technology Co., Ltd. | Feb 17, 2022 | SESE |
| K212011 | Vinyl Powder Free Examination Glove | Top Glove Vietnam Company Limited | Feb 14, 2022 | SESE |
| K213019 | Vinyl Exam Gloves | Hebei Astro Medical Supply Co., Ltd. | Jan 5, 2022 | SESE |
| K212436 | NBR Synthetic Nitrile Examination Gloves | Shandong Langtai International Trade Co., Ltd. | Dec 23, 2021 | SESE |
| K213144 | Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors | Shen Wei USA, Inc. | Dec 22, 2021 | SESE |
| K213006 | Vinyl Examination Gloves | Taian Hengchang Medical Technology Co., Ltd. | Dec 21, 2021 | SESE |
| K211865 | 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
