Profeel Double Gloving Non-Latex
by WRP Asia Pacific Sdn. Bhd. 8 variants
Ref P3375-62
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Overview
Polysulfone surgical gloves, such as the Polyisoprene Surgical Gloves, are sterile non-latex gloves made from polyisoprene. These gloves are designed for medical professionals to wear during procedures and are a reliable choice for their hygiene and comfort. With features like durable construction and easy maintenance, they make an excellent addition to any healthcare facility.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number9557795PI-SG017Q 09557795011113 | Date19 Nov 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Polyisoprene Surgical Gloves, Powder Free, Sterile
- Model / Reference
- P3375-62
- Primary DI / UDI-DI
- 09557795011113
- Basic UDI-DI
- 9557795PI-SG017Q
- EMDN Code
- T01010203 Polyisopren surgical gloves
- Device Class
- Class IIa
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- MY-MF-000004690
- Authorised representative
- REMESCO HANDELSGESMBH AT-AR-000002669
Other devices from WRP Asia Pacific Sdn. Bhd.
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No