Identity
- Trade Name
- Medicom SafeBasics FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Medicom SafeBasics True Fit Thin - Nitrile Chemo-tested Medical Examination Gloves with Textured Fingertips - Blue - Powder-Free - Non-Sterile - Extra Large FDA UDI
- Model / Reference
- 1185-E FDA UDI
- Description
- Medicom SafeBasics True Fit Thin - Nitrile Chemo-tested Medical Examination Gloves with Textured Fingertips - Blue - Powder-Free - Non-Sterile - Extra Large FDA UDI
Identifiers
- Catalog Number
- 1185-E FDA UDI
- Primary DI / UDI-DI
- 10686864040832 FDA UDI
- 510(k) Number
- K200019 FDA UDI
- FDA Product Code
- LZC FDA UDILZA FDA UDIQDO FDA UDI
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Medicom SafeBasics by AMD Medicom Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Nitrile examination/treatment glove, non-powdered, non-antimicrobial.
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Cleared under the same submission
K200019 also covers:
- Medicom SafeBasics — AMD Medicom Inc
- Medicom SafeBasics — AMD Medicom Inc
- Medicom SafeBasics — AMD Medicom Inc
- Medicom SafeBasics — AMD Medicom Inc
- Medicom SafeBasics — AMD Medicom Inc
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
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
- Manufacturer
- AMD Medicom Inc
Sources (1)
- FDA UDI 7c2e53e7-5889-42ef-aa34-792c2014ec64 38 fields · synced May 30, 2026