Solid Wound Dressing With Permanently Bound Antimicrobial Agent
SHA is the FDA product code for Solid Wound Dressing With Permanently Bound Antimicrobial Agent, a class II device type, regulated under 21 CFR 878.4013. FDA's definition for this code reads: "A solid wound dressing with permanently bound antimicrobial agent consists of a solid wound dressing containing antimicrobial permanently bound to the substrate surface. The solid wound dressing is used to cover and protect a wound, to absorb exudate, and to maintain appropriate moisture balance within the wound and...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SHA
- Device name
- Solid Wound Dressing With Permanently Bound Antimicrobial Agent
- FDA definition
- A solid wound dressing with permanently bound antimicrobial agent consists of a solid wound dressing containing antimicrobial permanently bound to the substrate surface. The solid wound dressing is used to cover and protect a wound, to absorb exudate, and to maintain appropriate moisture balance within the wound and is intended for use only on external cutaneous (skin) wounds. The solid wound dressing is provided sterile in a form able to hold structural integrity. Antimicrobials are used for protectant purposes only to reduce microbial growth within the solid wound dressing while in use, or to provide an antimicrobial barrier to microbial penetration through the solid wound dressing. This classification does not include solid wound dressings containing a medically important antimicrobial as defined in the special controls.
- Regulation
- 21 CFR 878.4013
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SHA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2026 | 1 |
Applicants with the most clearances
Product code SHA| Applicant | Clearances |
|---|---|
| Amferia AB | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code SHA.
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