Identity
- Trade Name
- Gel Therapy Glove, Pair FDA UDI
- Generic Name
- Skin treatment/dressing-supportive glove/mitten, reusable FDA UDI
- Model / Reference
- 786 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00614464007866 FDA UDI
- FDA Product Code
- FMP FDA UDI
- GMDN Term
- Skin treatment/dressing-supportive glove/mitten, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Skin treatment/dressing-supportive glove/mitten, reusable
Gel Therapy Glove, Pair by SILIPOS Holding LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin treatment/dressing-supportive glove/mitten, reusable.
- Bulk Gel Therapy Glove — SILIPOS Holding LLC · Class I
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
- SILIPOS Holding LLC
Sources (1)
- FDA UDI db5cd263-ce3d-42b3-9ec1-bb2373ce4abf 32 fields · synced May 30, 2026