Identity
- Trade Name
- MEDLINE FDA UDI
- Generic Name
- Surgical/examination garment kit FDA UDI
- Device Name
- STERILE CUT GLOVES A2 CUT RESISTANT XL FDA UDI
- Model / Reference
- STERCUT2XL FDA UDI
- Description
- STERILE CUT GLOVES A2 CUT RESISTANT XL FDA UDI
Identifiers
- Catalog Number
- STERCUT2XL FDA UDI
- Primary DI / UDI-DI
- 10193489196757 FDA UDI
- FDA Product Code
- LYU FDA UDI
- GMDN Term
- Surgical/examination garment kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical/examination garment kit
Medline by Medline Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/examination garment kit.
- Lab Coats Knitted Cuffs & Collar with Pockets, 2X-Large, White — Dynarex Corp. · Class I
- GRYPHON BRANDS — Gryphon Brands Inc. · Class I
- GRYPHON BRANDS — Gryphon Brands Inc. · Class I
- ASP MEDICAL — Asp Global, LLC · Class I
- Centurion — Centurion Medical Products · Class II
- VR — POLYCONVERSIONS, INC. · Class I
- VR — POLYCONVERSIONS, INC. · Class I
- Safehand — Winsight International Solutions, Inc. · Class II
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI f9528ddb-2435-4d32-8dd0-83d17467c747 35 fields · synced Jun 1, 2026