Felix Nonwovens makes spunbond nonwovens, films and laminates for the medical sector at our plant in Eskişehir Organized Industrial Zone, Türkiye. Gown, coverall and drape manufacturers and surgical set assemblers use our raw materials, and we also supply finished medical products (see Medical finished goods). Felix is ISO 13485 and ISO 9001 certified, is CE, EUDAMED and FDA registered, and holds three FDA 510(k) clearances for its Bodygard SFS surgical gowns and Myflon surgical mask.
Surgical gown fabrics
- AAMI Level 3 and AAMI Level 4 gown fabrics: Bodygard gown fabrics made of a breathable, textile-like Superfiber spunbond that is comfortable to wear. They are treated to repel low-surface-tension fluids and come in standard or hydrophobic versions for extra protection against strike-through. They conform to EN 13795 High Performance (critical area), with high MVTR (over 4,000 g/m²/24 h). They are liquid- and blood-proof, and ETO sterilisation is available.
- SFS impervious gown fabric (SFS65): nonwoven on both sides gives a cloth-like feel, and a microporous film inside makes it breathable yet resistant to liquid and blood. It conforms to EN 13795 High Performance (critical area) and is recommended for surgical gowns and drapes.
- Film-reinforced, SMS and SMMS gowns: film reinforcement gives a Level 4 liquid barrier in zones A, B and C of the gown. The gowns also offer lint and abrasion resistance, microbial resistance and flame resistance that meets CPSC 1610.
Coverall fabric
Microprotect is a laminated microporous fabric for disposable coveralls. Our Bodygard FLX2000 coverall made from it is approved to PPE Category III, Type 5/6. It protects against dry particles and limited liquid chemical splashes, while the breathable structure lets air out of the garment and reduces heat stress.
Surgical drape fabrics
Our custom-designed drape materials are used as disposable drapes and compresses:
- Spunsuper Biflex (Spunsper54): a two-layer spunbond and film laminate
- Spunsuper Triplex (Spunsper63): three layers. A highly absorbent hydrophilic spunbond is hot-melt laminated to a micro-embossed barrier film. It absorbs liquid very quickly and holds it in the barrier layer.
- Spunsuper Trink Biflex: a laminate for drapes and gowns
- Viscose Biflex and Viscose Triplex: barrier and breathable film laminates for the A-class segment
We state that our fabrics made to EN 13795 are produced at least twice the minimum limit values required in the operating room.
EN 13795 explained: Standard vs High Performance, critical vs less-critical zones
EN 13795 is the European standard for surgical gowns, surgical drapes and clean air suits used as medical devices. The current edition is EN 13795-1:2019 for gowns and drapes and EN 13795-2:2019 for clean air suits. It sorts products along two axes:
- Two performance levels. Standard Performance and High Performance. High Performance is meant for procedures with a higher infection risk because of their length, the amount of blood and irrigation fluid, or mechanical stress on the gown. Standard Performance suits shorter procedures where large amounts of fluid are not expected. The standard does not say which level to use for a given operation. The hospital decides after its own risk assessment.
- Critical and less-critical product areas. Critical areas are the parts most likely to carry infective agents to or from the wound, such as the front and sleeves of a gown. On our gowns the critical zones are, at minimum, the front from chest to knees (zone A) and the sleeves from the cuff to above the elbow (zone B). The manufacturer must identify the critical and less-critical areas of each product.
Key requirements for surgical gowns in the EN 13795 performance tables:
| Property (test method) | Standard, critical | Standard, less critical | High, critical | High, less critical |
|---|---|---|---|---|
| Resistance to liquid penetration, cm H₂O (EN ISO 811, formerly EN 20811) | ≥ 20 | ≥ 10 | ≥ 100 | ≥ 10 |
| Resistance to wet microbial penetration, BI (EN ISO 22610) | ≥ 2.8 | not required | 6.0 (no penetration) | not required |
| Resistance to dry microbial penetration, log10 CFU (EN ISO 22612) | not required | ≤ 2 (max. 300 CFU) | not required | ≤ 2 (max. 300 CFU) |
| Microbial cleanliness, log10 CFU/dm² | ≤ 2 | ≤ 2 | ≤ 2 | ≤ 2 |
| Particulate cleanliness, IPM / linting, log10 lint count (ISO 9073-10) | ≤ 3.5 / ≤ 4.0 | ≤ 3.5 / ≤ 4.0 | ≤ 3.5 / ≤ 4.0 | ≤ 3.5 / ≤ 4.0 |
| Bursting strength dry / wet, kPa | ≥ 40 / ≥ 40 | ≥ 40 / not required | ≥ 40 / ≥ 40 | ≥ 40 / not required |
| Tensile strength dry / wet, N | ≥ 20 / ≥ 20 | ≥ 20 / not required | ≥ 20 / ≥ 20 | ≥ 20 / not required |
For surgical drapes the liquid-penetration requirement in the critical area is ≥ 30 cm H₂O (Standard) and ≥ 100 cm H₂O (High Performance). Our full guide to the standard is available as a PDF (EN 13795 guide).
Which Felix fabrics meet which level (as stated on our product pages):
- Bodygard AAMI Level 3 and AAMI Level 4 gown fabrics: EN 13795 High Performance, critical area.
- SFS65 impervious gown fabric: EN 13795 High Performance, critical area. Recommended for surgical gowns and drapes.
- Reinforced surgical gown fabric: AAMI and EN 13795 critical-area protection.
- SFS (spunbond/film/spunbond) fabrics: fully reinforced, so the barrier covers the whole gown and not only the critical zones. They have passed AAMI Level 3, AAMI Level 4 and EN 13795 critical-area tests in gown and drape fabrics.
- Spunsuper drape fabrics: made to EN 13795. The product pages do not name a performance level, so ask us about a specific fabric.
FDA 510(k) clearances
Three devices from Feliks Plastik are cleared by the US Food and Drug Administration under 510(k). All three fall under regulation 21 CFR 878.4040 (surgical apparel), Class II:
| 510(k) | Device name (as on the FDA page) | Product code | Cleared |
|---|---|---|---|
| K212111 | Myflon Surgical Mask Level 3 | FXX | 23 Jan 2022 |
| K202845 | Bodygard SFS Surgical Gown Level 3 | FYA | 24 Feb 2022 |
| K221139 | Bodygard SFS Surgical Gown Level 4 | FYA | 10 Nov 2022 |
Both gowns are poly-reinforced SMS/film/SMS (SFS) gowns. They meet ANSI/AAMI PB70:2012 Level 3 or Level 4 in both the critical zones (chest and arms) and the non-critical zones, and they are supplied sterile. The mask meets ASTM F2100 Level 3. The test standards are listed on our medical finished goods page. AAMI PB70 is the US classification and EN 13795 the European one. They use different tests, so a level in one system does not convert directly into the other.
SMS / SMMS and spunbond for medical
We produce spunbond (SS), SMS and SMMS for disposable surgical sets, gowns, visitor gowns, caps, shoe covers, masks and other hospital textiles. Full and partially reinforced fabrics are available where more protection is needed. SS, SMS and SMMS are 10–100 g/m², and we produce in widths of 160, 320, 400 and 540 cm, with slitting to customer widths.
Surgical incision film
Our transparent, breathable, hypoallergenic incise drape covers the operation site with its adhesive area and forms a barrier against bacteria. Standard widths are 30, 35, 45, 60 and 90 cm (codes CD30–CD90). It is used in bone, abdominal, chest and heart, plastic, ophthalmic and paediatric surgery. Details of lengths, film material and liner are available on request.
Laboratory and quality
Our laboratory tests strike-through time, wetback, liquid penetration resistance (water column) and other physical properties. We are certified to ISO 13485 (medical devices quality management) and ISO 9001. We are CE, EUDAMED and FDA registered and hold three FDA 510(k) clearances, which supports buyers in the EU, the US and Türkiye.
Also in our range
We also supply single-use warm-up jackets and emergency Mylar thermal blankets.
FAQ
Which gown fabric levels do you offer? AAMI Level 3, AAMI Level 4 and EN 13795 High Performance (critical area).
Are your fabrics breathable? Yes. Our AAMI and SFS gown fabrics have an MVTR above 4,000 g/m²/24 h.
Which certifications do you hold? ISO 13485 and ISO 9001. We are also CE, EUDAMED and FDA registered, and hold three FDA 510(k) clearances (K212111, K202845 and K221139).
What is EN 13795 High Performance? It is the higher of the two performance levels in EN 13795. In the critical area of a surgical gown it requires at least 100 cm H₂O resistance to liquid penetration and a wet microbial barrier of 6.0 BI (no penetration). Standard Performance requires 20 cm H₂O and 2.8 BI. Our Bodygard AAMI Level 3 and Level 4 gown fabrics and our SFS65 fabric conform to High Performance in the critical area.
What are critical and less-critical zones? Critical zones are the parts of a gown or drape most likely to transfer infective agents to or from the wound, such as the gown front and sleeves. They must meet stricter barrier requirements than the less-critical zones.
Are your gowns FDA cleared? Yes. The Bodygard SFS Surgical Gown Level 3 (K202845) and the Bodygard SFS Surgical Gown Level 4 (K221139) are FDA 510(k) cleared, as is the Myflon Surgical Mask Level 3 (K212111). The 510(k) holder is Feliks Plastik.
Can the fabrics be ETO sterilised? Yes. ETO sterilisation is available for our gown fabrics.
Do you also make finished gowns and drapes? Yes. See our medical finished goods page.
Request a quote
Tell us the fabric, weight, width and end product. Phone: +90 222 236 23 63. Email: info@felixnonwovens.com. Or use the contact form.