GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims
FDA 510(k) K193121 · Eco Medi Glove Sdn. Bhd.
510(k) numberK193121
Submission
- Device name
- GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims
- Applicant
- Eco Medi Glove Sdn. Bhd.
Perak, MY - Received
- November 12, 2019
- Decision date
- March 20, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K233560 | Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested…LZA · Traditional | 02/26/2024SE |
| K232764 | Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy…LZA · Traditional | 02/07/2024SE |
| K233405 | Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test ClaimLZA · Traditional | 12/28/2023SE |
| K220943 | Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and…LZA · Traditional | 07/19/2022SE |
| K202401 | Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims…KGO · Traditional | 02/17/2021SE |
| K181066 | Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested…LZA · Traditional | 09/26/2018SE |
| K171339 | EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy…LZA · Traditional | 07/07/2017SE |
| K161187 | EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy…LZA · Traditional | 09/09/2016SE |
| K161320 | EMG Pink Nitrile Examination Glove Powder FreeLZA · Traditional | 09/01/2016SE |
| K152937 | EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint ScentedLZA · Traditional | 06/23/2016SE |
Questions and answers
When was GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims cleared by the FDA?
GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims (K193121) received a 510(k) decision of Substantially Equivalent on March 20, 2020, 129 days after the submission was received.
What is the product code of K193121?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.