← Back to catalogue
Powder Free Nitrile Examination Gloves(Violet Blue)
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref KF-B-M
Identity
- Trade Name
- Nitrile Examination Gloves EUDAMEDPowder Free Nitrile Examination Gloves(Violet Blue) FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Nitrile Examination Gloves EUDAMED
- Model / Reference
- KF-B-M EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 18938531860093 EUDAMEDFDA UDI
- Basic UDI-DI
- 8938531860KLDVN2024YW EUDAMED
- 510(k) Number
- K202356 FDA UDI
- FDA Product Code
- LZA FDA UDI
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Powder Free Nitrile Examination Gloves(Violet Blue) by Kanglongda Vietnam Protection Technology Company Limited — Class I — FDA UDI — listed in FDA GUDID…
Cleared under the same submission
K202356 also covers:
- Bodyguard — Fastenal Company
- Bodyguard — Fastenal Company
- Bodyguard — Fastenal Company
- Bodyguard — Fastenal Company
- Powder Free Nitrile Examination Gloves(Blue) — KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED
- Powder Free Nitrile Examination Gloves(Cobalt Blue) — KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (2)
- FDA UDI 5f484bea-2af3-4b51-a040-d1018a76c6c2 33 fields · synced Oct 6, 2026
- EUDAMED d4170325-bba3-4ba9-b994-44427bf9f48e 61 fields · synced Jul 17, 2026