Powdered Vinyl Exam Gloves, White
FDA 510(k) K030927 · Copioumed Intl., Inc.
510(k) numberK030927
Submission
- Device name
- Powdered Vinyl Exam Gloves, White
- Applicant
- Copioumed Intl., Inc.
Sparks, NV, US - Received
- March 24, 2003
- Decision date
- April 17, 2003
- 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.
| 510(k) | Device | Decision |
|---|---|---|
| K021961 | Powder-Free Poly-Vinyl Exam Gloves, Color: WhiteLYZ · Traditional | 07/02/2002SE |
| K021743 | (Multiple Labels) Powder-Free Poly-Vinyl Exam Gloves, Color: YellowLZA · Traditional | 06/10/2002SE |
| K972624 | Poly (Vinyl) Exam Glove, Powder-FreeLYZ · Traditional | 11/06/1997SE |
| K971316 | Poly (Vinyl) Exam Glove, PowderedLYZ · Traditional | 08/27/1997SE |
| K965237 | Nurses Bouffant CapLYU · Traditional | 08/27/1997SE |
| K961342 | Shoe Cover, Non-SterileFXP · Traditional | 12/30/1996SE |
| K960999 | Isolation GownFYC · Traditional | 12/30/1996SE |
Questions and answers
When was Powdered Vinyl Exam Gloves, White cleared by the FDA?
Powdered Vinyl Exam Gloves, White (K030927) received a 510(k) decision of Substantially Equivalent on April 17, 2003, 24 days after the submission was received.
What is the product code of K030927?
The FDA product code is LYZ – Vinyl Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.