Globy
by Supermax Glove Manufacturing Sdn Bhd 10 variants
Ref XL
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955100345124B5 09551025332412 | Date24 Jun 2025 | StatusActive |
Official records
- EUDAMED public site 955100345124B5
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Powder Free Nitrile Examination Gloves
- Model / reference
- XL
- Primary DI / UDI-DI
- 09551025332412
- Basic UDI-DI
- 955100345124B5
- EMDN code
- T01020204 Nitrile examination / treatment gloves
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- MY-MF-000016722
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Supermax Glove Manufacturing Sdn Bhd
Properties
Other properties (14)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No