Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
FDA 510(k) K160411 · Cardinal Health, Inc.
510(k) numberK160411
Submission
- Device name
- Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
- Applicant
- Cardinal Health, Inc.
Waukegan, IL, US - Received
- February 16, 2016
- Decision date
- July 25, 2016
- 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 |
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| K221603 | Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD…LZH · Traditional | 12/20/2022SE |
| K211765 | Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse GownFYA · Traditional | 11/23/2021SE |
| K170198 | Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use…KGO · Traditional | 06/15/2017SE |
| K160875 | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with…KGO · Traditional | 07/11/2016SE |
| K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and…KGO · Traditional | 05/12/2016SE |
| K122696 | Powder-Free Nitrile Examination Gloves (Cool Blue)LZA · Traditional | 01/31/2013SE |
| K121897 | Protexis Latex Basic Sterile Powder-Free Surgical GlovesKGO · Special | 07/27/2012SE |
| K120934 | Protexis Latex Basic Sterile Latex Powder-Free Surgical Glove with Protein Content Label…KGO · Traditional | 05/23/2012SE |
| K111878 | Protexis Latex Blue with Neu-Thera Powder-Free Surgical GlovesKGO · Traditional | 09/29/2011SE |
| K110272 | Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy DrugKGO · Traditional | 06/08/2011SE |
Questions and answers
When was Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating cleared by the FDA?
Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating (K160411) received a 510(k) decision of Substantially Equivalent on July 25, 2016, 160 days after the submission was received.
What is the product code of K160411?
The FDA product code is LYZ – Vinyl Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.