Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
FDA 510(k) K232764 · Eco Medi Glove Sdn. Bhd.
510(k) numberK232764
Submission
- Device name
- Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- Applicant
- Eco Medi Glove Sdn. Bhd.
Taiping, MY - Received
- September 8, 2023
- Decision date
- February 7, 2024
- 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.
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|---|---|---|---|
| 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 |
| 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 |
| K193121 | GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with…LZA · Traditional | 03/20/2020SE |
| 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 Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate cleared by the FDA?
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K232764) received a 510(k) decision of Substantially Equivalent on February 7, 2024, 152 days after the submission was received.
What is the product code of K232764?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.