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Sign in to claim this brandElevate Textiles
US
Last updated May 23, 2026
What Elevate Textiles makes
Elevate Textiles manufactures reusable surgical gowns designed for general surgical procedures, along with reusable sterilization packaging and non-medicated surgical procedure kits. These products are intended for single-use applications within sterile environments, ensuring contamination control during medical interventions.
The company’s portfolio is classified under FDA’s Class II regulatory category, with devices authorised via 510(k) clearances and listed under the FDA’s Unique Device Identifier (UDI) system. Elevate Textiles operates from the United States, adhering to domestic regulatory requirements for medical textiles.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Elevate Textiles manufacture?
Elevate Textiles specializes in reusable medical textiles for sterile environments, including surgical gowns for general surgical procedures, reusable sterilization packaging, and non-medicated surgical procedure kits. These products are designed to maintain contamination control during medical interventions, replacing single-use alternatives with durable, reusable solutions.
Where is Elevate Textiles based, and does that affect its regulatory compliance?
Elevate Textiles is based in the United States, which means its devices must comply with FDA regulations. Since the company’s products fall under FDA’s Class II category, they are authorised through the 510(k) clearance process and are listed in the FDA’s Unique Device Identifier (UDI) system to ensure traceability and regulatory tracking.
Which regulatory registries or databases list Elevate Textiles’ devices?
Elevate Textiles’ devices are authorised via the FDA’s 510(k) clearance pathway and are included in the FDA’s Unique Device Identifier (UDI) system. This ensures their devices are officially tracked and listed in relevant regulatory databases, such as the FDA’s 510(k) database and UDI records, which verify compliance and traceability for healthcare providers.
How are Elevate Textiles’ devices classified by regulatory authorities?
Elevate Textiles’ devices are classified under FDA’s Class II regulatory category. This classification applies to products that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. Class II devices are authorised through the 510(k) process, which demonstrates their compliance with regulatory requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (43)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SRI Healthcare | WRAP04804800-4-SV-0MDGN-0 | FDA UDI | Class II | Active |
| SRI Healthcare | PREMSRGWNXLT04-SV-0MDGN-2XL | FDA UDI | Class II | Active |
| Burlington Industries | SURGWNMAXULT03-SV-0115F-0LG | FDA UDI | Class II | Active |
| SRI Healthcare | BTC070100000-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| SRI Healthcare | SURGWNMAXPRO-02-SV-0MDGN-0LG | FDA UDI | Class II | Active |
| SRI Healthcare | PREMSRGWNXLT-03-SV-0MDGN-2XL | FDA UDI | Class II | Active |
| Burlington Industries | SURGWNMAXULT03-SV-0115F-0MD | FDA UDI | Class II | Active |
| SRI Healthcare | SURGWNMAXPRO-02-SV-0MDGN-2XL | FDA UDI | Class II | Active |
| SRI Healthcare | PREMSRGWNXLT-03-SV-0MDGN-0LG | FDA UDI | Class II | Active |
| SRI Healthcare | PREMSRGWNXLT-03-SV-0MDGN-0XL | FDA UDI | Class II | Active |
| SRI Healthcare | PREMSRGWNXLT04-SV-0MDGN-0LG | FDA UDI | Class II | Active |
| SRI Healthcare | PREMSRGWNXLT-03-SV-0MDGN-0SM | FDA UDI | Class II | Active |
| Burlington Industries | SURGWNMAXULT03-SV-0115F-0XL | FDA UDI | Class II | Active |
| SRI Healthcare | BTC070110000-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| SRI Healthcare | BTC070122000-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| SRI Healthcare | MSC033054000-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| Burlington Industries | SURGWNMAXULT03-SV-0115F-2XL | FDA UDI | Class II | Active |
| SRI Healthcare | SHEET0540720-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| SRI Healthcare | SURGWNMAXPRO-02-SV-0MDGN-0MD | FDA UDI | Class II | Active |
| Burlington Industries | SURGWNMAXULT03-SV-0115F-0SM | FDA UDI | Class II | Active |
| SRI Healthcare | WRAP05307200-4-SV-0MDGN-0 | FDA UDI | Class II | Active |
| SRI Healthcare | DRAPE0721050-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| SRI Healthcare | BTC054100000-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| SRI Healthcare | WRAP03603600-4-SV-0MDGN-0 | FDA UDI | Class II | Active |
| SRI Healthcare | WRAP05405400-4-SV-0MDGN-0 | FDA UDI | Class II | Active |
| SRI Healthcare | PREMSRGWNXLT04-SV-0MDGN-0MD | FDA UDI | Class II | Active |
| SRI Healthcare | MSC022054000-4-SV-0MDGN-0 | FDA UDI | Class II | Active |
| SRI Healthcare | SHEET0420540-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| SRI Healthcare | SURGWNMAXPRO-02-SV-0MDGN-0XL | FDA UDI | Class II | Active |
| SRI Healthcare | DRAPE0430700-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| SRI Healthcare | SHEET0260360-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| SRI Healthcare | MSC033069000-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| SRI Healthcare | PREMSRGWNXLT04-SV-0MDGN-0XL | FDA UDI | Class II | Active |
| SRI Healthcare | SURGWNMAXPRO-02-SV-0MDGN-0SM | FDA UDI | Class II | Active |
| SRI Healthcare | MSC054064000-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| SRI Healthcare | DRAPE0560800-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| SRI Healthcare | DRAPE0430600-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| SRI Healthcare | BTC054076000-4-SV-0MDGN-0 | FDA UDI | Class II | Active |
| SRI Healthcare | PREMSRGWNXLT-03-SV-0MDGN-0MD | FDA UDI | Class II | Active |
| SRI Healthcare | SURGWNMAXPRO-02-SV-0MDGN-0SM | FDA UDI | Class II | Active |
| SRI Healthcare | SHEET0540600-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| SRI Healthcare | DRAPE0550720-4-SV-0MDGN-000 | FDA UDI | Class II | Active |
| Maxima Surgical Gown | K201351 | FDA 510(k) | Class II | Active |
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