Sterile Powder Free Synthetic Vinyl Patient Exam Glove
FDA 510(k) K012282 · Cypress Medical Products, Ltd.
510(k) numberK012282
Submission
- Device name
- Sterile Powder Free Synthetic Vinyl Patient Exam Glove
- Applicant
- Cypress Medical Products, Ltd.
Mc Henry, IL, US - Received
- July 20, 2001
- Decision date
- August 6, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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.
| 510(k) | Device | Decision |
|---|---|---|
| K021676 | Cypress Medical Products, LP Disposable Vaginal Speculum, Non-MetalHIB · Traditional | 07/12/2002SE |
| K972899 | Cypress Medical Products Aneroid SphygmomanometerDXQ · Traditional | 07/07/1998SE |
| K972849 | Isosafe Earloop Procedure Mask (Blue, Yellow)FXX · Traditional | 05/28/1998SE |
| K972883 | Isosafe Earloop Procedure Mask (Blue, Yellow)FXX · Traditional | 02/26/1998SE |
| K952367 | Cypress Medical Products Vinyl Examination GloveLYY · Traditional | 07/05/1995SE |
| K950254 | Cypress Medical Products Sterile Latex Examination GloveLYY · Traditional | 03/31/1995SE |
| K950109 | Cypress Medical Products Catheter (Insertion) Tray/With Out CatheterFCM · Traditional | 02/27/1995SESK |
| K950092 | Cypress Medical Products Catheter (Insertion) TrayFCM · Traditional | 02/27/1995SESK |
| K945082 | Cypress Medical Products StethoscopeLDE · Traditional | 12/08/1994SE |
| K921988 | Laceration Repair TrayMDM · Traditional | 11/19/1992SEKD |
Questions and answers
When was Sterile Powder Free Synthetic Vinyl Patient Exam Glove cleared by the FDA?
Sterile Powder Free Synthetic Vinyl Patient Exam Glove (K012282) received a 510(k) decision of Substantially Equivalent on August 6, 2001, 17 days after the submission was received.
What is the product code of K012282?
The FDA product code is LYZ – Vinyl Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.