Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest
FDA 510(k) K162858 · Careplus (M) Sdn Bhd
510(k) numberK162858
Submission
- Device name
- Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest
- Applicant
- Careplus (M) Sdn Bhd
Seremban, MY - Received
- October 12, 2016
- Decision date
- July 24, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K211621 | Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)KGO · Traditional | 10/06/2021SE |
| K203705 | Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or…LYY · Traditional | 08/20/2021SE |
| K201857 | Powder Free Nitrile Examination Glove Black and Dual Color White-BlueLZA · Traditional | 08/20/2021SE |
| K210724 | ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling…KGO · Traditional | 08/03/2021SE |
| K210656 | ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling…KGO · Traditional | 06/24/2021SE |
| K202765 | ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim…KGO · Traditional | 05/27/2021SE |
| K152593 | Latex Examination Glove Powder FreeLYY · Traditional | 02/25/2016SE |
| K142858 | POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)LZA · Traditional | 02/09/2015SE |
| K142862 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).LZA · Traditional | 01/16/2015SE |
Questions and answers
When was Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest cleared by the FDA?
Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest (K162858) received a 510(k) decision of Substantially Equivalent on July 24, 2017, 285 days after the submission was received.
What is the product code of K162858?
The FDA product code is LZC – Medical Glove, Specialty, a Class I (low risk) device regulated under 21 CFR 880.6250.