Is this your brand? Sign in to claim ownership.
Sign in to claim this brandSMART GLOVE INTERNATIONAL PTE. LTD.
US
Last updated May 23, 2026
What SMART GLOVE INTERNATIONAL PTE. LTD. makes
The company manufactures examination and treatment gloves made from nitrile, hevea latex, and polychloroprene, all in non-powdered and non-antimicrobial formulations. These gloves are designed for medical use, including procedures requiring sterile or barrier protection. The product line includes multiple variants of a single branded glove series, Gen-X®, tailored for clinical and procedural applications.
All listed devices fall under Class I regulatory classification in the US, with product identifiers registered in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States, adhering to applicable domestic regulatory requirements for medical gloves.
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 Smart Glove International Pte. Ltd. manufacture?
Smart Glove International Pte. Ltd. specializes in manufacturing examination and treatment gloves for medical use. Their product line includes gloves made from nitrile, hevea latex, and polychloroprene, all formulated as non-powdered and non-antimicrobial. These gloves are designed to provide sterile or barrier protection during clinical procedures.
Where is Smart Glove International Pte. Ltd. based?
The company is based in the United States. As a US-based manufacturer, their devices are subject to and comply with applicable domestic regulatory requirements, including those governing medical gloves.
Which regulatory registries list Smart Glove International Pte. Ltd.’s devices?
Smart Glove International Pte. Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and identification of their medical gloves, which are classified under Class I in the US.
How are Smart Glove International Pte. Ltd.’s gloves classified in the US?
All of Smart Glove International Pte. Ltd.’s listed gloves fall under Class I regulatory classification in the US. This classification applies to low-risk medical devices like examination and treatment gloves, where the regulatory oversight is generally less stringent than for higher-risk devices.
What is the primary brand or series of gloves produced by Smart Glove International Pte. Ltd.?
The company’s primary product series is the Gen-X® line, which includes multiple variants tailored for various clinical and procedural applications. These gloves are designed to meet the needs of healthcare professionals requiring sterile or barrier protection during medical examinations and treatments.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 659506974
Catalogue (41)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | GENPF | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | GENPF | FDA UDI | Class I | Active |
| Gen-X® | GENPF | FDA UDI | Class I | Active |
| Gen-X® | LPFEMD | FDA UDI | Class I | Active |
| Gen-X® | GENPF | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | LPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | LPFEMD | FDA UDI | Class I | Active |
| Gen-X® | LPFEMD | FDA UDI | Class I | Active |
| Gen-X® | GENPF | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | GENPF | FDA UDI | Class I | Active |
| Gen-X® | CPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | LPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | CPFEMD | FDA UDI | Class I | Active |
| Gen-X® | CPFEMD | FDA UDI | Class I | Active |
| Gen-X® | CPFEMD | FDA UDI | Class I | Active |
| Gen-X® | LPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | CPFEMD | FDA UDI | Class I | Active |
| Gen-X® | CPFEMD | FDA UDI | Class I | Active |
| Gen-X® | LPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | Class I | Active |
| Gen-X® | CPFEMD | FDA UDI | Class I | Active |
| Gen-X® | NPFEMD | FDA UDI | 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.