Is this your brand? Sign in to claim ownership.
Sign in to claim this brandCAREGLOVE GLOBAL SDN. BHD.
US
Last updated May 24, 2026
What CAREGLOVE GLOBAL SDN. BHD. makes
Careglove Global produces single-use examination and treatment gloves made from nitrile, natural rubber latex, and chloroprene. Their products include non-powdered nitrile gloves, antimicrobial latex gloves, and colored nitrile examination gloves, designed for medical and clinical use.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Careglove Global manufacture?
Careglove Global produces single-use gloves for medical and clinical use, including nitrile examination and treatment gloves, natural rubber latex gloves, and chloroprene gloves. Their most common products are non-powdered nitrile gloves and antimicrobial latex gloves, as well as colored nitrile examination gloves. These are designed for tasks requiring barrier protection in healthcare settings.
Where is Careglove Global based?
Careglove Global is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in available data.
Which regulatory registries list Careglove Global’s devices?
Careglove Global’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries track medical devices that have undergone the necessary regulatory pathways, such as the 510(k) premarket notification process, to demonstrate substantial equivalence to a legally marketed predicate device.
How are Careglove Global’s devices classified by regulatory authorities?
Careglove Global’s gloves are classified under the FDA’s Class I medical device category. Class I devices are generally considered to pose the lowest risk and often require only general controls (such as good manufacturing practices) for regulatory compliance, though specific labeling and performance requirements still apply.
What distinguishes Careglove Global’s gloves from other similar products?
Careglove Global’s gloves are differentiated by their material composition—including nitrile, natural rubber latex, and chloroprene—and specialized features like antimicrobial properties (in latex gloves) and powder-free formulations. Their product line also includes colored nitrile gloves, which may aid in visual identification during clinical procedures. These attributes align with common needs in healthcare settings for durability, comfort, and infection control.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- careplus.com
- —
- —
- [email protected]
- Phone
- +6067292130
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 865779649
Catalogue (50)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nitrilecare Blue Pf | Nitrile M gloves | FDA UDI | Class I | Active |
| Rubbercare Latex Pf | Latex XS gloves | FDA UDI | Class I | Active |
| Nitrile Examination Multicolor Pf | Nitrile XL gloves | FDA UDI | Class I | Active |
| Nitrile Examination Multicolor Pf | Nitrile XS gloves | FDA UDI | Class I | Active |
| Nitrilecare Elite | M gloves | FDA UDI | Class I | Active |
| Nitrilecare Elite | XXL gloves | FDA UDI | Class I | Active |
| Chloroprene Examination Pf | Chloroprene XS gloves | FDA UDI | Class I | Active |
| Nitrilecare Elite | L gloves | FDA UDI | Class I | Active |
| Orcare Surgical Latex Pf | 7.5 | FDA UDI | Class I | Active |
| Rubbercare Latex Pf | Latex M gloves | FDA UDI | Class I | Active |
| Nitrilecare Elite | S gloves | FDA UDI | Class I | Active |
| Nitrile Examination Multicolor Pf | Nitrile XXL gloves | FDA UDI | Class I | Active |
| Rubbercare Latex Pf | Latex L gloves | FDA UDI | Class I | Active |
| Nitrile Examination Multicolor Pf | Nitrile L gloves | FDA UDI | Class I | Active |
| Nitrilecare Premium | Nitrile XS gloves | FDA UDI | Class I | Active |
| Chloroprene Examination Pf | Chloroprene S gloves | FDA UDI | Class I | Active |
| Nitrile Examination Multicolor Pf | Nitrile S gloves | FDA UDI | Class I | Active |
| Nitrilecare Blue Pf | Nitrile S gloves | FDA UDI | Class I | Active |
| Orcare Surgical Latex Pf | 6.5 | FDA UDI | Class I | Active |
| Orcare Surgical Latex Pf | 5.5 | FDA UDI | Class I | Active |
| Nitrilecare Premium | Nitrile S gloves | FDA UDI | Class I | Active |
| Nitrilecare Blue Pf | Nitrile L gloves | FDA UDI | Class I | Active |
| Nitrilecare Blue Pf | Nitrile XXL gloves | FDA UDI | Class I | Active |
| Nitrilecare Elite | XL gloves | FDA UDI | Class I | Active |
| Nitrilecare Elite | XS gloves | FDA UDI | Class I | Active |
| Chloroprene Examination Pf | Chloroprene M gloves | FDA UDI | Class I | Active |
| Orcare Surgical Latex Pf | 8.0 | FDA UDI | Class I | Active |
| Nitrilecare Blue Pf | Nitrile XL gloves | FDA UDI | Class I | Active |
| Nitrilecare Blue Pf | Nitrile XS gloves | FDA UDI | Class I | Active |
| Nitrilecare Premium | Nitrile L gloves | FDA UDI | Class I | Active |
| Orcare Surgical Latex Pf | 8.5 | FDA UDI | Class I | Active |
| Nitrilecare Premium | Nitrile XL gloves | FDA UDI | Class I | Active |
| Rubbercare Latex Pf | Latex S gloves | FDA UDI | Class I | Active |
| Orcare Surgical Latex Pf | 9.0 | FDA UDI | Class I | Active |
| Nitrilecare Premium | Nitrile M gloves | FDA UDI | Class I | Active |
| Rubbercare Latex Pf | Latex XL gloves | FDA UDI | Class I | Active |
| Chloroprene Examination Pf | Chloroprene XL gloves | FDA UDI | Class I | Active |
| Nitrile Examination Multicolor Pf | Nitrile M gloves | FDA UDI | Class I | Active |
| Orcare Surgical Latex Pf | 7.0 | FDA UDI | Class I | Active |
| Nitrilecare Premium | Nitrile XXL gloves | FDA UDI | Class I | Active |
| Orcare Surgical Latex Pf | 6.0 | FDA UDI | Class I | Active |
| Chloroprene Examination Pf | Chloroprene L gloves | FDA UDI | Class I | Active |
| Powder Free Nitrile Examination Gloves, Blue (colored) | K172015 | FDA 510(k) | Class I | Active |
| Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | K250578 | FDA 510(k) | Class I | Active |
| Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) | K220859 | FDA 510(k) | Class I | Active |
| Powder Free Nitrile Examination Gloves, Blue Chemotest | K211666 | FDA 510(k) | Class I | Active |
| Latex Examination Glove Powder Free | K161833 | FDA 510(k) | Class I | Active |
| Powder Free Chloroprene Examination Glove Coloured (Blue, Green) | K213993 | FDA 510(k) | Class I | Active |
| Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | K230121 | FDA 510(k) | Class I | Active |
| Sterile Latex Surgical Glove, Powder Free | K190241 | FDA 510(k) | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Careglove Global Sdn Bhd Seremban Negeri Sembilan · MY FEI 3014164734