Vinyl Co-Polymer Powder Free Examination Gloves
FDA 510(k) K142409 · Grand Work Plastic Products Co., Ltd.
510(k) numberK142409
Submission
- Device name
- Vinyl Co-Polymer Powder Free Examination Gloves
- Applicant
- Grand Work Plastic Products Co., Ltd.
Zanhuang County, CN - Received
- August 27, 2014
- Decision date
- December 5, 2014
- 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 |
|---|---|---|
| K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsKGO · Traditional | 12/20/2023SE |
| K232039 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…LZA · Special | 08/09/2023SE |
| K230217 | Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy DrugsKGO · Traditional | 05/13/2023SE |
| K222892 | Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with…LZA · Traditional | 12/15/2022SE |
| K213574 | Nitrile Vinyl Blend Powder Free Examination Gloves (Black)LZA · Traditional | 07/12/2022SE |
| K220249 | Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs…LZA · Traditional | 05/26/2022SE |
| K220250 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…LZA · Traditional | 05/11/2022SE |
| K220240 | Vinyl Co-Polymer Powder-free Examination Gloves, BlackLYZ · Traditional | 03/31/2022SE |
| K102089 | Grand Work Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination GlovesLYZ · Traditional | 10/06/2010SE |
| K102094 | Powder Free Vinyl Patient Examination GlovesLYZ · Traditional | 10/05/2010SE |
Questions and answers
When was Vinyl Co-Polymer Powder Free Examination Gloves cleared by the FDA?
Vinyl Co-Polymer Powder Free Examination Gloves (K142409) received a 510(k) decision of Substantially Equivalent on December 5, 2014, 100 days after the submission was received.
What is the product code of K142409?
The FDA product code is LYZ – Vinyl Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.