Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)
FDA 510(k) K232070 · Better Care Plastic Technology Co., Ltd.
510(k) numberK232070
Submission
- Device name
- Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)
- Applicant
- Better Care Plastic Technology Co., Ltd.
Shenze County, CN - Received
- July 12, 2023
- Decision date
- October 11, 2023
- 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 |
|---|---|---|
| K242533 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low…LZA · Traditional | 03/18/2025SE |
| K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for…LZA · Traditional | 11/03/2023SE |
| K231567 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy…LZA · Traditional | 10/04/2023SE |
| K223713 | Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and…LZA · Traditional | 08/07/2023SE |
| K222449 | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And…LZC · Traditional | 08/27/2022SE |
| K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and…LZA · Traditional | 07/27/2022SE |
| K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)LZA · Traditional | 11/30/2018SE |
| K171898 | Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy DrugsKGO · Traditional | 08/18/2017SE |
| K171047 | Sterile Polyisoprene Powder Free Surgical GlovesKGO · Traditional | 06/22/2017SE |
| K140816 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)LZA · Traditional | 07/08/2014SE |
Questions and answers
When was Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) cleared by the FDA?
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) (K232070) received a 510(k) decision of Substantially Equivalent on October 11, 2023, 91 days after the submission was received.
What is the product code of K232070?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.