Identity
- Trade Name
- Medicom AssureTouch FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Medicom AssureTouch Advanced Force - Nitrile Medical Examination Gloves with Textured Fingertips - Chemotherapy Tested - Powder Free - Non-Sterile - Blue - X-Small FDA UDI
- Model / Reference
- 1220-A FDA UDI
- Description
- Medicom AssureTouch Advanced Force - Nitrile Medical Examination Gloves with Textured Fingertips - Chemotherapy Tested - Powder Free - Non-Sterile - Blue - X-Small FDA UDI
Identifiers
- Catalog Number
- 1220-A FDA UDI
- Primary DI / UDI-DI
- 10686864047015 FDA UDI
- 510(k) Number
- K091652 FDA UDI
- FDA Product Code
- LZA FDA UDILZC 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
- Not 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
Medicom AssureTouch by AMD Medicom Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- AMD Medicom Inc
Sources (1)
- FDA UDI e368dcb4-9ed5-4115-a804-41b5feb2fccc 39 fields · synced Jun 1, 2026