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Sign in to claim this brandSVS LLC
US
Last updated May 24, 2026
What SVS LLC makes
SVS LLC manufactures single-use medical textiles and protective barriers, including isolation gowns, non-adhesive retention bandages, and incontinence pants. Their product line also covers sterile gloves—both polyisoprene surgical gloves with antimicrobial properties and nitrile examination gloves without antimicrobial treatment—as well as absorbent underpads and intravenous line connectors designed to reduce needle-stick risks. Additionally, they produce a dry-heat blanket warming cabinet for medical settings.
The company’s devices are classified under FDA’s Class I and Class II categories, with all products listed in the FDA’s Unique Device Identifier (UDI) database. SVS LLC operates from the United States, adhering to applicable U.S. regulatory requirements for medical device authorization.
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 SVS LLC manufacture?
SVS LLC specializes in single-use medical textiles and protective barriers, including isolation gowns, non-adhesive device retention bandages, and incontinence pants. Their product line also includes sterile gloves—such as polyisoprene surgical gloves with antimicrobial properties and nitrile examination gloves without antimicrobial treatment—as well as absorbent underpads and intravenous line recessed-needle connectors. They also produce a dry-heat blanket warming cabinet for medical settings.
Where is SVS LLC based, and does that affect its regulatory compliance?
SVS LLC is based in the United States, which means its devices must comply with U.S. regulatory requirements for medical device authorization. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, they are subject to FDA oversight, including classification under applicable U.S. device categories.
Which regulatory registries or databases list SVS LLC’s devices?
SVS LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for authorized medical devices, helping healthcare providers and regulators identify and verify the products under the company’s portfolio.
How are SVS LLC’s devices classified under FDA regulations?
SVS LLC’s devices fall under FDA’s Class I and Class II categories. Class I generally includes low-risk devices requiring general controls, while Class II involves special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential risks, as outlined in FDA guidelines.
What distinguishes SVS LLC’s intravenous line recessed-needle connector from other similar products?
SVS LLC’s recessed-needle connector is designed to minimize needle-stick injuries, a common risk in intravenous line handling. By reducing exposure to sharp ends, it aligns with safety-focused medical device trends while maintaining compatibility with standard intravenous systems. The design reflects the company’s focus on protective barriers and risk mitigation in medical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- s2s-global.com
- —
- —
- [email protected]
- Phone
- 1-855-531-7699
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 831375089
Catalogue (785)
Page 16 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PremierPro | 8154 | FDA UDI | Class I | Active |
| PremierPro | 6636PP | FDA UDI | Class I | Active |
| PremierPro | 3303 | FDA UDI | Class I | Active |
| PremierPro | 7035W | FDA UDI | Class I | Active |
| PremierPro | 7503 | FDA UDI | Class II | Active |
| PremierPro Surgeons Glove | 43185 | FDA UDI | Class I | Active |
| PremierPro Surgeons Glove | 43160 | FDA UDI | Class I | Active |
| PremierPro | 6250 | FDA UDI | Class I | Active |
| PremierPro | 5094 | FDA UDI | Class I | Active |
| PremierPro Surgeons Glove | 43680 | FDA UDI | Class I | Active |
| PremierPro | 26124 | FDA UDI | Class I | Active |
| PremierPro | 4035 | FDA UDI | Class I | Active |
| PremierPro Lancet | 7580 | FDA UDI | Class II | Active |
| PremierPro | 6251 | FDA UDI | Class I | Active |
| PremierPro | 3661 | FDA UDI | Class I | Active |
| PremierPro | 2252 | FDA UDI | Class I | Active |
| PremierPro | 6442 | FDA UDI | Class I | Active |
| PremierPro | 6911 | FDA UDI | Class II | Active |
| PremierPro | 7226 | FDA UDI | N/A | Active |
| PremierPro | 6802 | FDA UDI | Class II | Active |
| PremierPro | 3822 | FDA UDI | Class II | Active |
| PremierPro | 6914 | FDA UDI | Class II | Active |
| PremierPro | 8944 | FDA UDI | Class I | Active |
| PremierPro | 3640 | FDA UDI | Class I | Active |
| PremierPro | 8976 | FDA UDI | Class I | Active |
| PremierPro | 2317 | FDA UDI | Class I | Active |
| PremierPro | 7227 | FDA UDI | N/A | Active |
| PremierPro | 2857P | FDA UDI | Class I | Active |
| PremierPro | 2161 | FDA UDI | Class I | Active |
| PremierPro Air Transfer Mats | 3730 | FDA UDI | Class II | Active |
| PremierPro | 2514 | FDA UDI | Class I | Active |
| PremierPro TSA High Viscosity Topical Skin Adhesive, 1.0ml | 3470 | FDA UDI | Class II | Active |
| PremierPro Surgeons Glove | 44660 | FDA UDI | Class I | Active |
| PremierPro™ | 31T20116 | FDA UDI | Class II | Active |
| PremierPro Surgeons Glove | 43155 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
SVS LLC has two recall records in the FDA database, initiated on October 1, 2018, and May 13, 2024. The records reflect one classified, one open, and one terminated status. The first involved complaints about skin irritation, glove disintegration with specific cleaning solutions, and mislabeling discrepancies (size mismatches between outer and inner packaging). The second was initiated following a mandatory FDA order for stock recovery and return of an imported item.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 13, 2024 | Z-2320-2024 | — | open, classified | Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner box indicating another size). |
| Oct 1, 2018 | Z-0487-2019 | — | terminated | This recall is due to a mandated order from the FDA for stock recovery and return of the imported item. |