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This page describes products and general use; it is not medical advice.
Short answer: Primapore is a Smith+Nephew adhesive island wound dressing: an absorbent non-woven pad with a non-adhesive wound-contact layer, surrounded by an adhesive border. The manufacturer describes it as an absorbent pad for wound protection from cuts and grazes. In the US FDA device database (GUDID) a Primapore record sits under product code KGX and is listed as exempt from premarket submission, which is not the same as 510(k)-cleared or “FDA approved”.
What is a Primapore wound dressing?
Smith+Nephew names it PRIMAPORE Adhesive Non-Woven Wound Dressing. Its Australia/NZ product page (checked 2026-11-01) describes an absorbent pad for wound protection from cuts and grazes, and lists it as flexible, conformable and breathable, with a low-allergy adhesive and a non-adhesive wound contact layer. The general product class is covered in what a wound dressing is.
The manufacturer lists it in its healthcare-in-the-home product range.
How it is built
An island dressing places the absorbent pad in the centre of an adhesive-backed strip, so the adhesive sits on the surrounding skin and not on the wound. In Primapore the pad is faced with a non-adhesive contact layer. That separates it from a contact-layer mesh such as the one described in what Adaptic is, which is not a standalone dressing, and from a loose non-adherent dressing pad that needs tape or a bandage to stay in place.
Is Primapore FDA approved? Regulatory record
In the NLM AccessGUDID record for Primapore Adhesive Dressing 10×8 cm (checked 2026-11-01), the company is Smith & Nephew Medical Limited, the description is “Non-woven adhesive wound dressing”, and the model number is 66000317. The record shows:
| Field | GUDID entry |
|---|---|
| Product code | KGX (Tape and Bandage, Adhesive) |
| Exempt from premarket submission | Yes (no 510(k) number listed) |
| Packaged sterile | Yes |
| Single use | Yes |
| Labeled as containing natural rubber latex | No |
Retail listings that say “FDA approved” go beyond what this record shows. The record does not state a device class.
Primapore sizes
The manufacturer’s Australia/NZ page lists these pack sizes (checked 2026-11-01). Other markets may list different ranges.
| Size (cm) | Pieces per pack |
|---|---|
| 8.3 x 6 | 5 |
| 6 x 8.3 | 50 |
| 7.2 x 5 | 50 |
| 8 x 10 | 20 |
| 8 x 15 | 20 |
| 10 x 20 | 20 |
For how island dressing dimensions work in general, see island dressing sizes.
Packaging and labeling
Per its GUDID record, the Primapore 10×8 cm dressing is packaged sterile, is single use, and is not labeled as containing natural rubber latex. The manufacturer’s page does not state composition details. For use instructions and warnings, refer to the instructions that come with the product.
Common misreadings
- Treating “exempt from premarket submission” as “FDA approved” or “510(k) cleared”.
- Assuming pack sizes are the same in every market; the table above is the Australia/NZ range.
FAQ
Is Primapore FDA approved?
The GUDID record lists product code KGX and shows the device as exempt from premarket submission, with no 510(k) number. It does not say “approved”.
What is Adaptic wound dressing?
Adaptic is a different product type: a non-adherent contact-layer dressing, not an adhesive island dressing like Primapore. See what Adaptic is.
What is wet to dry wound dressing?
It is not the same thing as Primapore. Primapore is a ready-made adhesive island dressing with a non-adhesive contact layer; see the build description above.
Is Primapore sterile and single use?
Yes, per the GUDID record for the 10×8 cm size: packaged sterile and single use.
Sources
- Smith+Nephew, PRIMAPORE product page (Australia/NZ): https://www.smith-nephew.com/en-au/pharmacy/product-range/healthcare-in-the-home/primapore, checked 2026-11-01.
- NLM AccessGUDID, Primapore Adhesive Dressing 10×8 cm (DI 05000223420222): https://accessgudid.nlm.nih.gov/devices/05000223420222, checked 2026-11-01.
