Identity
- Trade Name
- Stronghold PP/PE Isolation Gown (AAMI Level 2)-M FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10. FDA UDI
- Model / Reference
- SC200M FDA UDI
- Description
- This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850037694655 FDA UDI
- FDA Product Code
- OEA FDA UDI
- GMDN Term
- Isolation 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Isolation gown, single-use
Stronghold PP/PE Isolation Gown (AAMI Level 2)-M by The Stronghold Group LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- The Stronghold Group LLC
Sources (1)
- FDA UDI 86f73d6f-267e-4302-bfc6-8a6b44b01fc6 33 fields · synced Jun 6, 2026