Vinyl Examination Gloves
FDA 510(k) K213625 · Dezhou Hengchang Medical Technology Co., Ltd.
510(k) numberK213625
Submission
- Device name
- Vinyl Examination Gloves
- Applicant
- Dezhou Hengchang Medical Technology Co., Ltd.
Dezhou City, CN - Received
- November 17, 2021
- Decision date
- February 17, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYZ – Vinyl Patient Examination Glove
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6250
- Specialty
- General Hospital
A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Other 510(k)s with product code LYZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260860 | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)LYZ · Traditional | Basic Medical Technology, Inc. | 04/07/2026SE |
| K252467 | Disposable Vinyl Examination GlovesLYZ · Traditional | Viet Phu Trade and Import Export Co., Ltd. | 10/27/2025SE |
| K252505 | Powder-Free Vinyl Exam Gloves, clearLYZ · Traditional | Basic Medical Technology, Inc. | 08/28/2025SE |
| K241252 | Disposable Vinyl Examination GlovesLYZ · Traditional | Anqing Pukang Medical Technology Co., Ltd. | 05/20/2024SE |
| K230046 | Vinyl examination glovesLYZ · Traditional | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 03/25/2023SE |
| K221980 | Disposable Powder Free Vinyl Examination Gloves, Beige/ClearLYZ · Traditional | Ever Global (Vietnam) Enterprise Corporation | 02/06/2023SE |
| K220992 | Disposable Powder Free Vinyl Exam Glove, Black/Blue/PurpleLYZ · Traditional | Ever Global (Vietnam) Enterprise Corporation | 10/19/2022SE |
| K223008 | Disposable Vinyl Examination GlovesLYZ · Traditional | Jiangxi Handspro Products Solutions Co., Ltd. | 10/08/2022SE |
| K222442 | DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)LYZ · Traditional | Anhui Bytech Medical Supplies Co., Ltd. | 09/28/2022SE |
| K220055 | Disposable, vinyl examination gloves, YellowLYZ · Traditional | Dezhou Hengchang Medical Technology Co., Ltd. | 08/25/2022SE |
More from Dezhou Hengchang Medical Technology Co., Ltd.
Questions and answers
When was Vinyl Examination Gloves cleared by the FDA?
Vinyl Examination Gloves (K213625) received a 510(k) decision of Substantially Equivalent on February 17, 2022, 92 days after the submission was received.
What is the product code of K213625?
The FDA product code is LYZ – Vinyl Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.