Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs
FDA 510(k) K190403 · Ever Global (Vietnam) Enterprise Corporation
510(k) numberK190403
Submission
- Device name
- Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs
- Applicant
- Ever Global (Vietnam) Enterprise Corporation
Long Tanh District, VN - Received
- February 19, 2019
- Decision date
- September 6, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- LZA – Polymer Patient Examination Glove
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6250
- Specialty
- General Hospital
A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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 LZA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262542 | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder…LZA · Special | Top Glove Sdn. Bhd. | 09/09/2026SE |
| K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and…LZA · Traditional | Maxter Healthcare, Inc. | 09/09/2026SE |
| K260312 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs…LZA · Special | Gmp Medicare Sdn. Bhd. | 09/08/2026SE |
| K260794 | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT…LZA · Traditional | Kossan International Sdn Bhd | 08/18/2026SE |
| K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile…LZA · Special | O&M Halyard, Inc. | 07/21/2026SE |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua…LZA · Special | Hartalega NGC Sdn. Bhd. | 07/20/2026SE |
| K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with…LZA · Special | Sw Technologies, Inc. | 06/24/2026SE |
| K253824 | Powder Free Nitrile Examination Gloves Non-Sterile BlackLZA · Traditional | Kanglongda Vietnam Protection Technology Company… | 06/18/2026SE |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and…LZA · Special | Hartalega NGC Sdn. Bhd. | 06/17/2026SE |
| K260806 | Nitrile Disposable Examination GlovesLZA · Traditional | Vista Industries,, LLC | 06/03/2026SE |
More from Vista Industries,, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K252244 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…LZA · Special | 08/21/2025SE |
| K244034 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…LZA · Special | 02/06/2025SE |
| K221980 | Disposable Powder Free Vinyl Examination Gloves, Beige/ClearLYZ · Traditional | 02/06/2023SE |
| K220992 | Disposable Powder Free Vinyl Exam Glove, Black/Blue/PurpleLYZ · Traditional | 10/19/2022SE |
| K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…LZC · Abbreviated | 06/04/2020SE |
| K171422 | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink ColorLZA · Abbreviated | 06/11/2018SE |
| K170575 | Disposable Powder Free Vinyl Exam Glove, Clear/YellowLYZ · Abbreviated | 05/16/2017SE |
Questions and answers
When was Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs cleared by the FDA?
Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs (K190403) received a 510(k) decision of Substantially Equivalent on September 6, 2019, 199 days after the submission was received.
What is the product code of K190403?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.