Grand Work Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves
FDA 510(k) K102089 · Grand Work Plastic Products Co., Ltd.
510(k) numberK102089
Submission
- Device name
- Grand Work Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves
- Applicant
- Grand Work Plastic Products Co., Ltd.
Zanhuang County, CN - Received
- August 5, 2010
- Decision date
- October 6, 2010
- 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 |
| K142409 | Vinyl Co-Polymer Powder Free Examination GlovesLYZ · Traditional | 12/05/2014SE |
| K102094 | Powder Free Vinyl Patient Examination GlovesLYZ · Traditional | 10/05/2010SE |
Questions and answers
When was Grand Work Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves cleared by the FDA?
Grand Work Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves (K102089) received a 510(k) decision of Substantially Equivalent on October 6, 2010, 62 days after the submission was received.
What is the product code of K102089?
The FDA product code is LYZ – Vinyl Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.