Identity
- Trade Name
- SRI Healthcare FDA UDI
- Generic Name
- Isolation gown, reusable FDA UDI
- Device Name
- Gown, L3, M, 24-Pack NS FDA UDI
- Model / Reference
- 540000 FDA UDI
- Description
- Gown, L3, M, 24-Pack NS FDA UDI
Identifiers
- Catalog Number
- 540000 FDA UDI
- Primary DI / UDI-DI
- 00810019801655 FDA UDI
- 510(k) Number
- K031933 FDA UDI
- FDA Product Code
- FYA FDA UDI
- GMDN Term
- Isolation gown, reusable 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
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Isolation gown, reusable
SRI Healthcare by SRI Healthcare, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Isolation gown, reusable.
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Generic Polyester Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- Precaution/Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- ComPel Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- HENRY SCHEIN — HENRY SCHEIN, INC. · Class II
- Precaution/Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC · Class II
- Precaution/Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
Cleared under the same submission
K031933 also covers:
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
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
- SRI Healthcare, LLC
Sources (1)
- FDA UDI c236c3fd-c60e-432c-9829-366b8a49bba8 36 fields · synced Jun 8, 2026