Disposable Medical Nitrile Examination Gloves (Non sterile)
FDA 510(k) K212639 · Jiangsu Nanfang Medical Co., Ltd.
510(k) numberK212639
Submission
- Device name
- Disposable Medical Nitrile Examination Gloves (Non sterile)
- Applicant
- Jiangsu Nanfang Medical Co., Ltd.
Changzhou, CN - Received
- August 20, 2021
- Decision date
- December 8, 2021
- 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 |
| K222449 | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And…LZC · Traditional | Better Care Plastic Technology Co., Ltd. | 08/27/2022SE |
| 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 |
More from Aspen Glove Sdn. Bhd.
| 510(k) | Device | Decision |
|---|---|---|
| K212826 | Disposable Medical MaskFXX · Traditional | 01/19/2022SE |
Questions and answers
When was Disposable Medical Nitrile Examination Gloves (Non sterile) cleared by the FDA?
Disposable Medical Nitrile Examination Gloves (Non sterile) (K212639) received a 510(k) decision of Substantially Equivalent on December 8, 2021, 110 days after the submission was received.
What is the product code of K212639?
The FDA product code is LZC – Medical Glove, Specialty, a Class I (low risk) device regulated under 21 CFR 880.6250.