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Nitrile Disposable Examination Gloves
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref XLModel D5000Ref XSModel D2000Ref 559569Ref 559568Ref SModel D3000Ref 559567Ref MRef LModel D1100Ref XXLModel D9000Ref XXXLModel X3000-LModel D7000Model D8000Model X3000Ref 559670Model D1000Model D6000
Identity
- Device Name
- Nitrile Disposable Examination Gloves EUDAMED
- Model / Reference
- D5000 EUDAMEDXL EUDAMEDD2000 EUDAMEDXS EUDAMED559569 EUDAMED559568 EUDAMEDD3000 EUDAMEDS EUDAMED559567 EUDAMEDM EUDAMEDD1100 EUDAMEDL EUDAMEDXXL EUDAMEDD9000 EUDAMEDX3000-L EUDAMEDXXXL EUDAMEDD7000 EUDAMEDD8000 EUDAMEDX3000 EUDAMED559670 EUDAMEDD1000 EUDAMEDD6000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975016720048 EUDAMED16975016720369 EUDAMED06975016726920 EUDAMED06975016726913 EUDAMED16975016720437 EUDAMED06975016726906 EUDAMED16975016720444 EUDAMED16975016720512 EUDAMED16975016720055 EUDAMED16975016720406 EUDAMED16975016720284 EUDAMED16975016724176 EUDAMED16975016720147 EUDAMED16975016720239 EUDAMED16975016720192 EUDAMED16975016724145 EUDAMED16975016721144 EUDAMED16975016720130 EUDAMED16975016720376 EUDAMED16975016724121 EUDAMED16975016724152 EUDAMED16975016720277 EUDAMED06975016726937 EUDAMED16975016720291 EUDAMED16975016720529 EUDAMED16975016720536 EUDAMED16975016720185 EUDAMED16975016720307 EUDAMED16975016720253 EUDAMED16975016720390 EUDAMED16975016721137 EUDAMED16975016720321 EUDAMED16975016720383 EUDAMED16975016720260 EUDAMED16975016720451 EUDAMED16975016720338 EUDAMED16975016720116 EUDAMED16975016721175 EUDAMED16975016720222 EUDAMED
- Basic UDI-DI
- 697501672D50005M EUDAMED697501672D20004Y EUDAMED697501672D300057 EUDAMED697501672D11004W EUDAMED697501672D90006H EUDAMED697501672X3000L8H EUDAMED697501672D700063 EUDAMED697501672D80006A EUDAMED697501672X3000C3 EUDAMED697501672D10004R EUDAMED697501672D60005U EUDAMED
- Direct Marketing DI
- 06975016726920 EUDAMED06975016726913 EUDAMED06975016726906 EUDAMED06975016726937 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDNorway EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMEDEUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Nitrile Disposable Examination Gloves by Xingyu Medical Tech Co., Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212578 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697501672D50005M | Class I | Active |
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Manufacturer
- Manufacturer
- Xingyu Medical Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000018326
- Authorised Representative
- Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133
Sources (40)
- EUDAMED 253ae405-bf53-4f0a-b16c-dc7b52be9e5e 61 fields · synced Sep 18, 2026
- EUDAMED 7de6b56f-cd61-47d3-a3cf-6ad797361f62 61 fields · synced May 16, 2026
- EUDAMED c31e33fb-fa79-46d7-bd52-cd1b1cf92964 61 fields · synced May 16, 2026
- EUDAMED 4d35622e-018c-4881-b9d9-861e04b19850 61 fields · synced May 16, 2026
- EUDAMED 3ed0fb89-6b7b-44e2-bed3-14e72b5a8d4f 61 fields · synced May 16, 2026
- EUDAMED e77d3c66-7995-4cda-9a5c-07e51bbd3006 61 fields · synced May 16, 2026
- EUDAMED 411d4905-7607-4852-9263-9af3f5deb61b 61 fields · synced May 16, 2026
- EUDAMED 02e7eb32-0547-4c52-95a2-d071fb188afc 61 fields · synced May 16, 2026
- EUDAMED effb68f5-e103-4f58-8535-5291d22304e1 61 fields · synced May 17, 2026
- EUDAMED 4e2f1ab9-49d9-4c90-a850-17906039c778 61 fields · synced May 17, 2026
- EUDAMED 43305027-33d1-4a17-a124-bef191c87766 61 fields · synced May 17, 2026
- EUDAMED 7a945269-471d-408b-b1ab-a748aa452511 61 fields · synced May 17, 2026
- EUDAMED 352973d8-f4b5-4762-9893-5659adcdd424 61 fields · synced May 17, 2026
- EUDAMED 7b27a624-aea6-433a-bcf5-253460997797 61 fields · synced May 17, 2026
- EUDAMED 54bebf89-179f-4f22-b780-f3d78c927353 61 fields · synced May 17, 2026
- EUDAMED bdb5f870-d323-43e1-8e24-99689830b588 61 fields · synced May 17, 2026
- EUDAMED e2d3847f-6508-42e1-a6b2-4931ab6bab5f 61 fields · synced May 17, 2026
- EUDAMED c19fbc6c-bf81-4458-b947-d2ea7e9d16fb 61 fields · synced May 17, 2026
- EUDAMED 3a8a206b-f814-421f-83ad-5fb760778417 61 fields · synced May 17, 2026
- EUDAMED 5855d5e7-595d-457c-a3d9-c345799ae873 61 fields · synced May 17, 2026
- EUDAMED 8a75edca-2fde-4aad-99de-59b98483b483 61 fields · synced May 17, 2026
- EUDAMED d324a83b-4cc1-43d9-a8fa-66f34caba267 61 fields · synced May 17, 2026
- EUDAMED 865d4031-209e-40e6-98d0-de47206f6327 61 fields · synced May 18, 2026
- EUDAMED 41dd76c6-5d62-47e4-a3c8-bbea85a39f41 61 fields · synced May 18, 2026
- EUDAMED a43997eb-e0f8-4f86-bbaa-820d8c92c2e8 61 fields · synced Jul 9, 2026
- EUDAMED 75809ea5-c338-41bb-9944-0534ba503565 61 fields · synced Jul 12, 2026
- EUDAMED ab4ea5b1-e97c-4e32-81c1-13e96e485f4b 61 fields · synced Jul 13, 2026
- EUDAMED c30c3df8-4cd8-4cf3-938f-742b3e3a114d 61 fields · synced Jul 13, 2026
- EUDAMED 33196b94-7234-4dd1-abd6-6840a25eef20 61 fields · synced Jul 14, 2026
- EUDAMED d247a285-0cfa-443d-afe3-75a31b48161c 61 fields · synced Jul 14, 2026
- EUDAMED 3b49cd82-5f12-4599-a086-f96e1d9dce28 61 fields · synced Jul 16, 2026
- EUDAMED 4d764846-26c9-4855-8f18-56369ccf05f3 61 fields · synced Jul 21, 2026
- EUDAMED 7d7ce446-c68a-4a2f-ac27-5740158e1ade 61 fields · synced Jul 21, 2026
- EUDAMED 55afb8b9-f966-4901-95a8-cb266e4921a5 61 fields · synced Jul 21, 2026
- EUDAMED b45d3fd6-382a-4e21-9510-a888483478a7 61 fields · synced Jul 26, 2026
- EUDAMED ce50c42d-4066-4205-a6ac-299fac16a3ad 61 fields · synced Jul 30, 2026
- EUDAMED b4624827-3b09-419f-93a4-06c3a9db1882 61 fields · synced Aug 1, 2026
- EUDAMED 4d372e1a-5004-473f-b497-417d554682f1 61 fields · synced Aug 4, 2026
- EUDAMED 115b0e1b-c18b-4f18-9c4c-04629ed7461e 61 fields · synced Sep 18, 2026
- FDA 510(k) K212578 1 fields · synced May 18, 2026