Identity
- Trade Name
- Regard FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- AAMI Level 3 Surgical Gown, Reinforced SMS, Sterile XX Large FDA UDI
- Model / Reference
- A3ISRGSTXXL-REG FDA UDI
- Description
- AAMI Level 3 Surgical Gown, Reinforced SMS, Sterile XX Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00326053117763 FDA UDI
- 510(k) Number
- K192290 FDA UDI
- FDA Product Code
- FYA FDA UDI
- GMDN Term
- Surgical gown, single-use FDA UDI
Classification
- Device Class
- Class II 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
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
No
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 gown, single-use
Regard by Resource Optimization & Innovation, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- T7 — Stryker Corp. · Class II
Cleared under the same submission
K192290 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Resource Optimization & Innovation, L.l.c.
Sources (1)
- FDA UDI 8feeb1eb-ed84-436f-a502-f147d1fff16b 34 fields · synced May 30, 2026