Identity
- Trade Name
- Medicom SafeTouch FDA UDI
- Generic Name
- Vinyl examination/treatment glove, non-powdered FDA UDI
- Device Name
- Medicom SafeTouch EverStrong - Vinyl - Medical Examination Gloves - Powder-Free - Non-Sterile - Clear - X-Large FDA UDI
- Model / Reference
- 1129-D FDA UDI
- Description
- Medicom SafeTouch EverStrong - Vinyl - Medical Examination Gloves - Powder-Free - Non-Sterile - Clear - X-Large FDA UDI
Identifiers
- Catalog Number
- 1129-D FDA UDI
- Primary DI / UDI-DI
- 10686864014796 FDA UDI
- 510(k) Number
- K182115 FDA UDI
- FDA Product Code
- LYZ FDA UDI
- GMDN Term
- Vinyl examination/treatment glove, non-powdered 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: Vinyl examination/treatment glove, non-powdered
Medicom SafeTouch by AMD Medicom Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vinyl examination/treatment glove, non-powdered.
- Life Guard — Lifeguard Inc. · Class I
- BASIC — Intco Medical Industries, Inc. · Class I
- Walgreens — WALGREEN CO. · Class I
- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
- Inspire — K2 HEALTH PRODUCTS · Class I
- SYNA MEDICAL — MEDLINE INDUSTRIES, INC. · Class I
- Life Guard — Lifeguard Inc. · Class I
- Durasafe — Durasafe Inc. · Class I
Cleared under the same submission
K182115 also covers:
- Medicom AssureTouch Shield — AMD Medicom Inc
- Medicom AssureTouch Shield — AMD Medicom Inc
- Medicom AssureTouch Shield — AMD Medicom Inc
- Medicom AssureTouch Shield — AMD Medicom Inc
- Medicom AssureTouch Shield — AMD Medicom Inc
- Medicom SafeTouch — AMD Medicom Inc
- Medicom SafeTouch — AMD Medicom Inc
- Medicom SafeTouch — AMD Medicom Inc
- Medicom SafeTouch — 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 2f41a860-2e0a-4d47-9c21-8630caf7ed87 38 fields · synced May 29, 2026