Innerbloc LR Surgical Gowns (Reusable 100X)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K032631 FDA 510(k)
- FDA Product Code
- FYA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4040 FDA 510(k)
- Regulation Number
- 878.4040 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Innerbloc LR Surgical Gowns are reusable surgical gowns designed to protect both patients and healthcare personnel during surgical and medical procedures. Constructed from Gore LR Fabric, these gowns provide a barrier against microorganisms, body fluids, and particulate matter, ensuring contamination control in sterile environments.
These gowns are intended for reuse and are supplied in a pack of 100 units. They are classified under product code FYA and have been cleared by the FDA via a 510(k) submission (K032631) as substantially equivalent to a predicate device. The gowns are intended for use in general and plastic surgery settings, adhering to regulatory standards for reusable surgical attire.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Innerbloc Lr Surgical Gowns Based on Gore Lr Fabric (Reusable 100x ..., Innerbloc Lr Surgical Gowns Based on Gore Lr Fabric (Reusable 100x) 510 ..., LAC-MAC INNERBLOC LR SURGICAL GOWNS - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032631 | Class II | Active |
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Manufacturer
- Manufacturer
- Lac Mac, Ltd.
Sources (1)
- FDA 510(k) K032631 24 fields · synced Oct 6, 2026