FDA Registration
Active
🇲🇾 Malaysia
CAREGLOVE GLOBAL SDN BHD
Reg #: 3014164734
·
FEI: 3014164734
·
Expires 2026
Products
6
Proprietary Names
38
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- CAREGLOVE GLOBAL SDN BHD
- Registration Number
- 3014164734
- FEI Number
- 3014164734
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lot 17479, Lorong Senawang 3/2,, Off Jln Senawang 3, Senawang Ind Estate
- City
- Seremban Negeri Sembilan
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K172015
Owner / Operator
- Firm Name
- Careglove Global Sdn Bhd
- Operator Number
- 10051431
- Address
- Lot 17479, Lorong Senawang 3/2,, Off Jln Senawang 3, Senawang Ind Estate
- City
- Seremban
- State
- Negeri Sembilan
- Postal Code
- 70450
- Country
- MY
- Correspondent
- Kwee Shyan Lim
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 |
|---|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2024-12-11 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-01-15 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-05-16 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-05-16 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-05-16 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2020-01-02 |
Proprietary Names
6202 - Ultracare Latex Exam Glove - S - NS
6203 - Ultracare Latex Exam Glove - Unisize - NS
6204 - Ultracare Latex Exam Glove - L - NS
powder-free nitrile examination gloves with aloe vera, green (tested for use with chemotherapy drugs)
DR SMART BLUE NITRILE, NITRILECARE BLUE NITRILE EXAMINATION POWDER FREE GLOVES
Nitrile Examination Gloves Powder Free (Green, Orange, Purple, White & Black)
GLOVEPLUS PWD GP40100
GLOVEPLUS PWD GP44100
GLOVEPLUS PWD GP48100
GLOVEPLUS PWD GP46100
Rubbercare
GLOVEPLUS PWD GP42100
SW N02840X Nitrile Examination Glove
NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK)
GLOVEPLUS PF GPPFT46100
GLOVEPLUS PF GPPFT48100
Guardian
GLOVEPLUS PF GPPFT42100
GLOVEPLUS PF GPPFT40100
Ultra Care Plus
LATEX EXAMINATION GLOVES POWDER FREE
Chloroprene Examination Gloves Powder Free (Blue, Green)
Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
Ambithix
SW N70034X Exam Glove
N18817X Biodegradable powder free nitrile examination glove, low dermatitis,potential claim
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE CHEMOTEST
STERILE LATEX SURGICAL GLOVES, POWDER FREE
PA-070886275 - Formula 1 - Pdr - Sm
PA-070886267 - Formula 1 - Pdr - Lg
CR-MLC - Formula 1 - Pdr - Lg
6103 - Formula One Latex Exam Glove - Unisize - NS
PA-070886259 - Formula 1 - Pdr - Med
CR-MSC - Formula 1 - Pdr - Sm
CR-MMC - Formula 1 - Pdr - Med
6104 - Formula One Latex Exam Glove - L - NS
6102 - Formula One Latex Exam Glove - S - NS
SW N30134X Exam Glove
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device