Nitrile examination gloves
by Hygiea Medical Technology (Beijing) Co., Ltd. 11 variants
Ref NGLGRE01 LModel HMGLNEBU01(XS, S, M, L, XL, XXL); HMGLNEBK01(XS, S, M, L, XL, XXL); HMGLNEVT01(XS, S, M, L, XL)
Active
CE MDR 510(k)
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number697633971NitrilegloveN8 06976339710023 | Date5 Apr 2024 | StatusActive |
| United States | FDA 510(k) 510(k) | NumberK891805 | Date12 May 1989 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 24 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Specification
- Device Name
- Nitrile examination gloves
- Model / Reference
- HMGLNEBU01(XS, S, M, L, XL, XXL), HMGLNEBK01(XS, HMGLNEVT01(XS, XL), NGLGRE01 L
- Primary DI / UDI-DI
- 06976339710023
- Basic UDI-DI
- 697633971NitrilegloveN8
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000041007
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hygiea Medical Technology (Beijing) Co., Ltd.
See all devices from Hygiea Medical Technology (Beijing) Co., Ltd. →
Properties
Other properties (13)
- Sterile: No
- 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