Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
FDA 510(k) K222449 · Better Care Plastic Technology Co., Ltd.
510(k) numberK222449
Submission
- Device name
- Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
- Applicant
- Better Care Plastic Technology Co., Ltd.
Shenze County, CN - Received
- August 15, 2022
- Decision date
- August 27, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZC – Medical Glove, Specialty
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6250
- Specialty
- General Hospital
A disposable medical glove (examination or surgeons) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.
Other 510(k)s with product code LZC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252313 | Cardinal Health Nitrile Examination Gloves Extended CuffLZC · Traditional | Cardinalhealth | 01/14/2026SE |
| K243959 | Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with…LZC · Traditional | Lingshi Hongruida Health Protection Technology… | 02/24/2025SE |
| K221157 | JR MedicLZC · Abbreviated | Jr Engineering & Medical Technologies (M) Sdn.… | 08/30/2022SE |
| K220545 | Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsLZC · Traditional | Hl Rubber Industries Sdn Bhd | 05/26/2022SE |
| K220491 | Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsLZC · Traditional | Hainan Asther Medical Equipment Co., Ltd. | 05/14/2022SE |
| K220353 | Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy DrugsLZC · Traditional | Niujian Technology Co., Ltd. | 03/31/2022SE |
| K213910 | Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy DrugsLZC · Traditional | Changzhou Universal Medical Equipment Co., Ltd. | 03/10/2022SE |
| K213325 | Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy DrugsLZC · Traditional | Anhui Xinyisheng Medical Technology Co.,Ltd | 01/28/2022SE |
| K213076 | AspenMed+LZC · Abbreviated | Aspen Glove Sdn. Bhd. | 12/20/2021SE |
| K212639 | Disposable Medical Nitrile Examination Gloves (Non sterile)LZC · Traditional | Jiangsu Nanfang Medical Co., Ltd. | 12/08/2021SE |
More from Jiangsu Nanfang Medical Co., Ltd.
| 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 |
| K232070 | Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and…LZA · Traditional | 10/11/2023SE |
| 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 |
| 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 Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) cleared by the FDA?
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) (K222449) received a 510(k) decision of Substantially Equivalent on August 27, 2022, 12 days after the submission was received.
What is the product code of K222449?
The FDA product code is LZC – Medical Glove, Specialty, a Class I (low risk) device regulated under 21 CFR 880.6250.