Vinyl examination gloves
FDA 510(k) K230046 · Guangdong Kingfa Sci. & Tech.Co., Ltd.
510(k) numberK230046
Submission
- Device name
- Vinyl examination gloves
- Applicant
- Guangdong Kingfa Sci. & Tech.Co., Ltd.
Qingyuan, CN - Received
- January 6, 2023
- Decision date
- March 25, 2023
- 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 |
| 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 |
| K220469 | Disposable Vinyl Examination GloveLYZ · Traditional | Chifeng Huawei Medical Science&Technology Co.… | 06/16/2022SE |
More from Chifeng Huawei Medical Science&Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K233723 | Medical surgical maskFXX · Traditional | 07/29/2024SE |
| K231155 | Biodegradable Medical surgical maskFXX · Traditional | 11/07/2023SE |
| K221983 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder…LZA · Traditional | 04/27/2023SE |
| K222612 | Powder-Free Latex examination glovesLYY · Traditional | 11/25/2022SE |
| K222714 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…LZA · Special | 10/07/2022SE |
| K221887 | Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile…LZA · Traditional | 09/24/2022SE |
| K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…LZA · Special | 04/27/2022SE |
| K213450 | Medical surgical mask (Black mask, Level 1 and Level 3)FXX · Traditional | 04/05/2022SE |
| K211220 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…LZA · Traditional | 07/22/2021SE |
| K203593 | Patient Examination GlovesLZA · Traditional | 03/19/2021SE |
Questions and answers
When was Vinyl examination gloves cleared by the FDA?
Vinyl examination gloves (K230046) received a 510(k) decision of Substantially Equivalent on March 25, 2023, 78 days after the submission was received.
What is the product code of K230046?
The FDA product code is LYZ – Vinyl Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.