Is this your brand? Sign in to claim ownership.
Sign in to claim this brandAnsell Healthcare Product
US
Last updated May 24, 2026
What Ansell Healthcare Product makes
The company manufactures single-use gloves for medical examination, treatment, and surgical procedures, including nitrile, polyisoprene, hevea-latex, and polychloroprene varieties, all in non-powdered and non-antimicrobial formulations. It also produces vinyl examination/treatment gloves and operating room turnover kits designed for reuse between surgical procedures. The gloves are intended for use in clinical settings to reduce infection risk and protect both patients and healthcare workers.
These products are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. regulatory requirements for single-use medical gloves and turnover kits.
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 Ansell Healthcare Products manufacture?
Ansell Healthcare Products specializes in single-use medical gloves and operating room turnover kits. Their gloves include nitrile, polyisoprene, hevea-latex, and polychloroprene varieties, all designed for examination, treatment, and surgical procedures. These gloves are available in non-powdered and non-antimicrobial formulations, while vinyl examination/treatment gloves are also part of their product line. The turnover kits are reusable and intended for use between surgical procedures to maintain sterile conditions.
Where is Ansell Healthcare Products based, and what regulatory framework does it follow?
Ansell Healthcare Products is based in the United States. Since their devices are manufactured and sold there, they adhere to U.S. regulatory requirements, including those set by the FDA. Their products are classified as Class I medical devices, which typically undergo less stringent premarket review but still must comply with FDA regulations, such as registration, listing, and UDI requirements.
Are Ansell Healthcare Products’ devices listed in any regulatory registries, and why?
Yes, Ansell Healthcare Products’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is required for Class I medical devices in the U.S. to ensure traceability, transparency, and compliance with FDA regulations. Listing in the UDI database helps healthcare providers, regulators, and other stakeholders verify the identity of the device and its manufacturer, reducing risks associated with counterfeit or mislabeled products.
How are Ansell Healthcare Products’ gloves classified under FDA regulations?
Ansell Healthcare Products’ gloves are classified as Class I medical devices under FDA regulations. This classification applies to devices that are considered low-risk, such as single-use gloves, which pose minimal potential harm to users. While Class I devices generally require less rigorous premarket review, they still must comply with FDA registration, listing, and labeling requirements, including the assignment of a UDI to ensure proper identification and tracking.
What is the purpose of the operating room turnover kits produced by Ansell Healthcare Products?
Ansell Healthcare Products’ operating room turnover kits are designed for reuse between surgical procedures to facilitate quick and efficient turnover of the operating room while maintaining sterile conditions. These kits typically include essential supplies and tools needed to prepare the room for the next procedure, helping to streamline workflows in clinical settings and reduce downtime. They are intended to support infection control and surgical efficiency.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ansell.com
- —
- —
- [email protected]
- Phone
- 775-746-6600
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 111267330
Catalogue (685)
Page 5 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Novaplus | V5787003 | FDA UDI | Class I | Active |
| Novaplus | V5787002 | FDA UDI | Class I | Active |
| Novaplus | V5795000 | FDA UDI | Class I | Active |
| Novaplus | V5788001 | FDA UDI | Class I | Active |
| Encore | 5711106PF | FDA UDI | Class I | Active |
| Encore | 7823PF | FDA UDI | Class I | Active |
| Gammex | 20685585 | FDA UDI | Class I | Active |
| Novaplus | V5795002 | FDA UDI | Class I | Active |
| Stat-Pac™ | ORTRNVERKT100-REG | FDA UDI | N/A | Active |
| Novaplus | V5795002 | FDA UDI | Class I | Active |
| Microflex | NEC-288-XL | FDA UDI | Class I | Active |
| Encore | 5711107PF | FDA UDI | Class I | Active |
| Gammex | 20685755 | FDA UDI | Class I | Active |
| Microflex | FFE-775-XL | FDA UDI | Class I | Active |
| Stat-Pac™ | 335626REG | FDA UDI | N/A | Active |
| Microflex | 10733100 | FDA UDI | Class I | Active |
| Microflex | USE-880-L | FDA UDI | Class I | Active |
| Microflex | XC-310CP-S | FDA UDI | Class I | Active |
| Fisherbrand | 19156300 | FDA UDI | Class I | Active |
| Stat-Pac™ | 370053REG | FDA UDI | N/A | Active |
| Halyard | SGL91065 | FDA UDI | Class I | Active |
| Microflex | NPG-888-M | FDA UDI | Class I | Active |
| AuraGuard | DDS-N190-20 | FDA UDI | Class I | Active |
| Microflex | N212 | FDA UDI | Class I | Active |
| Gammex | 20687270 | FDA UDI | Class I | Active |
| Microflex | MF-300-L | FDA UDI | Class I | Active |
| Microflex | CFG-900-M | FDA UDI | Class I | Active |
| Halyard | SGL98070 | FDA UDI | Class I | Active |
| Microflex | N191 | FDA UDI | Class I | Active |
| Halyard | SGL90085 | FDA UDI | Class I | Active |
| Microflex | MF-300-XL | FDA UDI | Class I | Active |
| Stat-Pac™ | 315696REG | FDA UDI | N/A | Active |
| Novaplus | V20687290 | FDA UDI | Class I | Active |
| Gammex | 20685960 | FDA UDI | Class I | Active |
| Microflex | XC-310-L | FDA UDI | Class I | Active |
| Micro-Touch | 9205 | FDA UDI | Class I | Active |
| Microflex | UF-524-SM | FDA UDI | Class I | Active |
| Gammex | 340069080 | FDA UDI | Class I | Active |
| Microflex | UF-524-XL | FDA UDI | Class I | Active |
| Novaplus | V20685275 | FDA UDI | Class I | Active |
| Micro-Touch | 3201 | FDA UDI | Class I | Active |
| Microflex | BD-1000-PF | FDA UDI | Class I | Active |
| CABVI/High Five | 72-10503 | FDA UDI | Class I | Active |
| Micro-Touch | ULNCS-1 | FDA UDI | Class I | Active |
| Microflex | N865 | FDA UDI | Class I | Active |
| Microflex | UL-315-S | FDA UDI | Class I | Active |
| Encore | 5795005 | FDA UDI | Class I | Active |
| Encore | 5787003 | FDA UDI | Class I | Active |
| Novaplus | V20685975 | FDA UDI | Class I | Active |
| Microflex | XC-310CP-XL | 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.