Identity
- Trade Name
- Regard™ FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- Gown Iso Pullover AAMI 4 2XL 40gsm FDA UDI
- Model / Reference
- A4ISOP2XLNS-REG FDA UDI
- Description
- Gown Iso Pullover AAMI 4 2XL 40gsm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10326053121514 FDA UDI
- 510(k) Number
- K222128 FDA UDI
- FDA Product Code
- QPC FDA UDI
- GMDN Term
- Isolation 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Isolation 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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Cleared under the same submission
K222128 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 56b997a9-01c2-4a38-9696-583731362d2a 34 fields · synced May 31, 2026