Identity
- Trade Name
- Medicom AssureTouch FDA UDI
- Generic Name
- Polychloroprene surgical glove, non-powdered FDA UDI
- Device Name
- Medicom AssureTouch Sense - Polychloroprene Surgical Gloves - Powder Free - Sterile - Natural White - Size 5.5 FDA UDI
- Model / Reference
- 1145-5.5 FDA UDI
- Description
- Medicom AssureTouch Sense - Polychloroprene Surgical Gloves - Powder Free - Sterile - Natural White - Size 5.5 FDA UDI
Identifiers
- Catalog Number
- 1145-5.5 FDA UDI
- Primary DI / UDI-DI
- 10686864059858 FDA UDI
- 510(k) Number
- K112654 FDA UDI
- FDA Product Code
- KGO FDA UDI
- GMDN Term
- Polychloroprene surgical glove, non-powdered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4460 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polychloroprene surgical glove, non-powdered
Medicom AssureTouch by AMD Medicom Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polychloroprene surgical glove, non-powdered.
- Gammex — Bosma Enterprises · Class I
- Sempermed Syntegra IR Polyisoprene Surgical Glove — SEMPERMED USA, INC.
- GAMMEX — Ansell Healthcare Product · Class I
- PremierPro Surgeons Glove — SVS LLC · Class I
- Sempermed Syntegra IR Polyisoprene Surgical Glove — SEMPERMED USA, INC.
- HALYARD — Ansell Healthcare Product · Class I
- Criterion CR Surgeons Glove — HENRY SCHEIN, INC. · Class I
- Biogel® Neoderm® — Mölnlycke Health Care AB · Class I
Cleared under the same submission
K112654 also covers:
- Medicom — AMD Medicom Inc
- Medicom — AMD Medicom Inc
- Medicom — AMD Medicom Inc
- Medicom — AMD Medicom Inc
- Medicom — AMD Medicom Inc
- Medicom — AMD Medicom Inc
- Medicom — AMD Medicom Inc
- Medicom — AMD Medicom Inc
- Medicom — AMD Medicom Inc
- Medicom — AMD Medicom Inc
- Medicom — AMD Medicom Inc
- Medicom — AMD Medicom 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 2ce10cf1-a744-4034-a9d5-75e9843f4a76 38 fields · synced May 31, 2026