JR Medic
FDA 510(k) K221157 · Jr Engineering & Medical Technologies (M) Sdn. Bhd.
510(k) numberK221157
Submission
- Device name
- JR Medic
- Applicant
- Jr Engineering & Medical Technologies (M) Sdn. Bhd.
Hulu Selangor, MY - Received
- April 21, 2022
- Decision date
- August 30, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
| 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 |
| 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 |
|---|---|---|
| K222350 | Sterile Nitrile Surgical Gloves Powder FreeKGO · Abbreviated | 04/13/2023SE |
| K221626 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy…LZA · Abbreviated | 12/07/2022SE |
| K222348 | JR MedicLYY · Abbreviated | 10/27/2022SE |
| K221169 | JR MEDIC Nitrile Examination Gloves Powder Free- BlackLZA · Abbreviated | 10/25/2022SE |
| K222349 | JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)LZA · Abbreviated | 10/21/2022SE |
| K212827 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy…LZC · Abbreviated | 12/06/2021SE |
| K192328 | JR.MEDIK Latex Surgeons Gloves Powder FreeKGO · Abbreviated | 03/10/2020SE |
| K192333 | Blue Nitrile Examination Gloves Powder FreeLZA · Abbreviated | 01/24/2020SE |
| K192329 | Blue Latex Examination Powder Free GlovesLYY · Abbreviated | 11/25/2019SE |
Questions and answers
When was JR Medic cleared by the FDA?
JR Medic (K221157) received a 510(k) decision of Substantially Equivalent on August 30, 2022, 131 days after the submission was received.
What is the product code of K221157?
The FDA product code is LZC – Medical Glove, Specialty, a Class I (low risk) device regulated under 21 CFR 880.6250.