Identity
- Trade Name
- First Aid Only FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- Gown, XXXL impervious FDA UDI
- Model / Reference
- 362002 FDA UDI
- Description
- Gown, XXXL impervious FDA UDI
Identifiers
- Catalog Number
- 362002 FDA UDI
- Primary DI / UDI-DI
- 00738743007214 FDA UDI
- FDA Product Code
- LYU FDA UDI
- GMDN Term
- Surgical gown, single-use 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical gown, single-use
First Aid Only by Acme United Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical gown, single-use.
- Halyard — O&M HALYARD, INC. · Class II
- Yellow gown with elastics (length 120 cm) — Omnia Spa · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- Beaver Visitec Inter — GRI Medical & Electronic Technology Co., Ltd. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- T7 — Stryker Corp. · 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
- Acme United Corp.
Sources (1)
- FDA UDI 311d80f7-47a1-4358-ac58-45b26bd9bbf8 35 fields · synced Jun 20, 2026