Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinfor…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211422 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)
These gowns are classified as surgical protective apparel, designed to provide barrier protection against microorganisms, body fluids, and particulate contamination during surgical procedures. The Level 2 Standard Surgical Gown offers basic fluid resistance, while the Level 3 Standard and Reinforced Surgical Gowns provide enhanced protection for higher-risk procedures, including reinforced areas for increased durability.
The gowns are intended for single-use in sterile operating room settings and are supplied sterile. They are manufactured from non-woven materials and comply with FDA 510(k) clearance (K211422) and MDR requirements. Available in standard sizes, they must be stored in a clean, dry environment to maintain sterility and integrity.
Frequently asked questions
What types of surgical procedures are these gowns designed to protect against, and how do the different levels differ in protection?
These gowns are designed to protect against microorganisms, body fluids, and particulate contamination during surgical procedures. The Level 2 Standard Surgical Gown provides basic fluid resistance for lower-risk surgeries. The Level 3 Standard Surgical Gown offers enhanced protection for moderate-risk procedures. The Level 3 Reinforced Surgical Gown includes reinforced areas for added durability, making it ideal for high-risk or lengthy surgeries where extra barrier protection is needed.
Are these gowns reusable, or are they intended for single-use only?
These gowns are explicitly intended for single-use only in sterile operating room settings. They are supplied sterile and should not be reused to maintain infection control standards.
What storage conditions are required to keep these gowns sterile and intact?
To preserve sterility and integrity, these gowns must be stored in a clean, dry environment away from direct sunlight, moisture, or contaminants. Proper storage ensures the barrier protection remains effective until use.
What regulatory pathways have these gowns undergone, and which advisory committee reviewed them?
These gowns have undergone FDA 510(k) clearance (K211422) and comply with MDR (Medical Device Regulation) requirements. The review was conducted under the General, Plastic Surgery advisory committee category (SU) and classified as Substantially Equivalent under a traditional clearance process.
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: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 ..., Level 2 Standard Surgical Gown Level 3 Standard Surgical Gown Level 3 ..., Sterile Surgical Gowns | Level 2 & Level 3 Protection | Nova Surgix
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K211422 | Class II | Active |
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Manufacturer
- Manufacturer
- JiangSu MedPlus Non-Woven Manufacturer Co., Ltd
- FDA Applicant
- Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.
Sources (2)
- FDA 510(k) K211422 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 11, 2026