Identity
- Trade Name
- ProtectX FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- AAMI LEVEL 3 DISPOSABLE PROTECTIVE GOWN OVER THE HEAD WITH THUMB LOOP NONSTERILE EXTRA LARGE BLUE FDA UDI
- Model / Reference
- LTF-0218-25-B FDA UDI
- Description
- AAMI LEVEL 3 DISPOSABLE PROTECTIVE GOWN OVER THE HEAD WITH THUMB LOOP NONSTERILE EXTRA LARGE BLUE FDA UDI
Identifiers
- Catalog Number
- LTF-0218-25-B FDA UDI
- Primary DI / UDI-DI
- 20860005250060 FDA UDI
- 510(k) Number
- K211538 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Isolation gown, single-use
ProtectX by The Azac Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K211538 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Azac Group
Sources (1)
- FDA UDI 6df2cbd4-0b09-4f20-92d2-4309923d0ef6 35 fields · synced Jun 1, 2026