FDA Registration
Active
🇲🇾 Malaysia
Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
Reg #: 3016785252
·
FEI: 3016785252
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- JR ENGINEERING &MEDICAL TECHNOLOGIES (M) SDN BHD
- Registration Number
- 3016785252
- FEI Number
- 3016785252
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LOT 8 & 10 JLN ZURAH, LOT 1& 3, JLN ZURAH 1A/1,PUSAT PERINDUSTRIAN 2
- City
- RASA Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K212827
Owner / Operator
- Firm Name
- JR ENGINEERING &MEDICAL TECHNOLOGIES (M) SDN BHD
- Operator Number
- 10065964
- Address
- LOT 8 & 10 JLN ZURAH, LOT 1& 3, JLN ZURAH 1A/1,PUSAT PERINDUSTRIAN 2
- City
- RASA
- State
- Selangor
- Postal Code
- 44200
- Country
- MY
US Agent
- Business Name
- Liberty Management Group Ltd.
- Contact Name
- Manoj Zacharias
- Address
- 75 Executive Drive,, Suite 114,
- City
- Aurora
- State
- IL
- ZIP
- 60504
- Country
- US
- [email protected]
- Phone
- 630 2702921
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2022-01-19 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2022-01-19 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2022-01-19 |
Proprietary Names
Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
Jr Medic Blue Nitrile Examination Powder Free Gloves tested for use with chemotherapy drugs
Establishment Types
Manufacture Medical Device