Identity
- Trade Name
- Knobby Donning Gloves FDA UDI
- Generic Name
- Utility glove FDA UDI
- Device Name
- A device made of natural latex intended to assist patients and caregivers in donning and removing compression stockings and garments without causing damage to the stocking (e.g. from nails, jewelry). This device will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device. FDA UDI
- Model / Reference
- 591R FDA UDI
- Description
- A device made of natural latex intended to assist patients and caregivers in donning and removing compression stockings and garments without causing damage to the stocking (e.g. from nails, jewelry). This device will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 591RPRM FDA UDI
- Primary DI / UDI-DI
- 00745129159221 FDA UDI
- FDA Product Code
- IKX FDA UDI
- GMDN Term
- Utility glove FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 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
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: Utility glove
Knobby Donning Gloves by Sigvaris, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Utility glove.
- VIVE — VIVE HEALTH LLC · Class I
- Specfit — Vallen Distribution, Inc. · Class I
- Specfit — Vallen Distribution, Inc. · Class I
- Specfit — Vallen Distribution, Inc. · Class I
- Specfit — Vallen Distribution, Inc. · Class I
- VR — POLYCONVERSIONS, INC. · Class I
- Latex Free Donning Gloves — SIGVARIS, INC. · Class I
- Textile Donning Gloves — SIGVARIS, INC. · 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 |
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Manufacturer
- Manufacturer
- Sigvaris, Inc.
Sources (1)
- FDA UDI 227ec9da-99aa-48af-97b4-2635053a66db 36 fields · synced Jun 8, 2026