Felix Nonwovens makes the nonwovens, films and laminates for medical products, and also converts them into finished single-use goods for hospitals, distributors and private-label partners. Because the fabric and the finished product come from the same plant in Eskişehir, Türkiye, quality is controlled from raw material to the packed product. Felix is ISO 13485 and ISO 9001 certified, is CE, EUDAMED and FDA registered, and holds three FDA 510(k) clearances (two surgical gowns and one surgical mask). Our finished goods are sold under the Bodygard (Bodyguard) and Myflon brands.
Surgical gowns
- SMS, SMMS and reinforced surgical gowns: film-reinforced gowns give a Level 4 liquid barrier in zones A, B and C. Under the standard, the critical zones are at least the front from chest to knees (A) and the sleeves from cuff to above the elbow (B). The gowns offer fluid resistance against blood strike-through, lint and abrasion resistance, microbial resistance and flame resistance that meets CPSC 1610. They meet the AAMI Level 4 liquid barrier standard.
- SFS gowns: made from our SFS65 fabric, which conforms to EN 13795 High Performance (critical area).
- Bodygard SFS Surgical Gown Level 3 and Level 4 (FDA 510(k) cleared): poly-reinforced SMS/film/SMS (SFS) gowns, ultrasonically bonded, blue, 60 g/m², in sizes M, L, XL and XXL. They meet ANSI/AAMI PB70:2012 Level 3 (K202845) or Level 4 (K221139) in both the critical zones (chest and arms) and the non-critical zones. Single use, supplied sterile (ethylene oxide, SAL 10⁻⁶).
- Patient and visitor gowns: made from PP spunbond.
EN 13795 grades in brief
EN 13795 (current edition EN 13795-1:2019) is the European standard for surgical gowns and drapes. It has two performance levels, Standard and High Performance, and splits each product into critical and less-critical areas. High Performance is meant for long or fluid-intensive procedures. In the critical area of a 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. Less-critical areas need at least 10 cm H₂O at either level. The hospital chooses the level after a risk assessment. Our SFS gowns are made from SFS65 fabric, which conforms to High Performance in the critical area. The full requirement table is on our medical nonwovens page. The FDA clearances above refer to AAMI PB70 levels, the US classification. EN 13795 is the European one, and a level in one system does not convert directly into the other.
Disposable coveralls
The Bodygard FLX2000 coverall is made of laminated microporous fabric and approved to PPE Category III, Type 5/6. It protects against dry particles and limited liquid chemical splashes, such as paint spraying. Features:
- a breathable structure that lets air out and reduces sweating stress
- a two-way zipper with wind flaps
- elastic cuffs, waist and ankles for fit and freedom of movement
- silicone-free and low-lint
Surgical drapes
Surgical drapes are available in sterile and non-sterile versions.
- Utility drapes with tape: Bodyguard universal and multi-procedure packs and drapes, from half drapes to U-shaped and bar drapes. They carry the maximum flame-resistance rating, are low-lint to cut airborne bacterial transmission, have fabric reinforcement to control fluid run-off, and include tube management systems.
- Poly-tissue fenestrated utility drape: an all-purpose, multi-layer drape for simple procedures. It is laminated with a water-repellent layer, fenestrated and poly-lined, white with blue non-glare tissue, and individually packaged and sterilised.
- Tissue / poly / tissue medical drape sheets: layered drape sheets that keep a barrier between the sterile field and its surroundings.
- Surgical incise drape: a transparent adhesive incision film in widths of 30–90 cm.
Operating room products
- Myflon Clean operating table cover: with Hydroknit super-absorbent technology. Felix introduced it about ten years ago. It improves infection control and fluid control, protects the table, and speeds up cleaning between surgeries.
- Myflon operating room turnover kits: curated kits for fast changeover between procedures, including the table cover.
- Operating room towels and absorbent OR walking pads.
Surgical masks
The Myflon ASTM Level 3 surgical mask has FDA 510(k) clearance as the Myflon Surgical Mask Level 3 (K212111, cleared 23 Jan 2022). We describe Myflon as Türkiye’s first FDA 510(k) cleared surgical mask brand. The mask is single-use and supplied non-sterile, for high fluid and aerosol risk such as operating procedures.
- Three-layer, flat-pleated, blue mask with ear loops: a blue PP spunbond outer layer, a white PP meltblown filter layer and a white PP spunbond inner layer
- Spunbond/elastic film/spunbond ear loops and a coated-wire nosepiece; size 175 × 95 mm
- Not made with natural rubber latex
- Meets ASTM F2100 Level 3. Bacterial and particle filtration efficiency results were above 99%.
Staff and patient care
- Bodygard single-use scrub suits: polypropylene scrubs with lower air and wound bacterial contamination than conventional cotton. The Extra Comfort version uses SUPERSOFT® nonwoven.
- Disposable nonwoven washing gloves: for patient washing and bathing, made of FDA-regulated materials in line with EU MDR and CE requirements.
- Elastic nonwoven bandages.
- Single-use warm-up jackets and emergency thermal blankets.
FDA 510(k) clearances: test details
All three devices are cleared for Feliks Plastik under 21 CFR 878.4040 (surgical apparel), Class II. The values below come from the FDA 510(k) summaries.
| 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 |
Bodygard SFS Surgical Gowns, Level 3 and Level 4
- Barrier class: ANSI/AAMI PB70:2012 Level 3 (K202845) and Level 4 (K221139), in critical and non-critical zones
- Water resistance: AATCC 127 hydrostatic pressure above 50 cm H₂O; AATCC 42 impact penetration below 1.0 g
- Synthetic blood: ASTM F1670, no penetration at 2 psi (13.8 kPa) (both gowns)
- Viral penetration: ASTM F1671, no detectable transfer of Phi-X174 bacteriophage (Level 4 gown)
- Flammability: 16 CFR 1610 Class I. Linting: ISO 9073-10, log10 below 4
- Strength: breaking above 30 N (ASTM D5034), tearing above 20 N (ASTM D5587), seams above 50 N
- Breathability: ASTM D6701 water vapour transmission, average 4,360 g/m²/day
- Biocompatibility: ISO 10993-5 and ISO 10993-10, non-cytotoxic, non-irritating and non-sensitising. Ethylene oxide residuals below ISO 10993-7 limits
- Packaging: ASTM F88, ASTM F2096, ASTM F1980 and ASTM D4169 passed
Myflon Surgical Mask Level 3
- ASTM F2100-19 Level 3
- Fluid resistance: ASTM F1862, passed at 160 mmHg
- Bacterial filtration efficiency: ASTM F2101, ≥ 98% acceptance criterion, passed
- Particle filtration efficiency: ASTM F2299, ≥ 98% acceptance criterion, passed
- Differential pressure: EN 14683, below 6.0 mm H₂O/cm²
- Flammability: 16 CFR 1610 Class 1
- Biocompatibility: ISO 10993-5 and ISO 10993-10, non-cytotoxic, non-irritating and non-sensitising
- Single use, non-sterile, for over-the-counter use
Private label and contract manufacturing
We produce for distributors and brands. Sterile or non-sterile supply is confirmed for these products: the Bodygard SFS Surgical Gowns Level 3 and Level 4 are supplied sterile (ethylene oxide), the Myflon Surgical Mask Level 3 is non-sterile, and the poly-tissue fenestrated drape is individually packaged and sterilised. Private label, own-brand labelling and a range of packing formats are available, and sterile options for other products are discussed per product.
FAQ
Which certifications cover your finished goods? Felix is ISO 13485 and ISO 9001 certified, and CE, EUDAMED and FDA registered. Three products have FDA 510(k) clearance: the Myflon Surgical Mask Level 3 (K212111) and the Bodygard SFS Surgical Gown Level 3 (K202845) and Level 4 (K221139).
Are your gowns FDA cleared? Yes. The Bodygard SFS Surgical Gown Level 3 (K202845, cleared 24 Feb 2022) and the Bodygard SFS Surgical Gown Level 4 (K221139, cleared 10 Nov 2022) are FDA 510(k) cleared under product code FYA. The 510(k) holder is Feliks Plastik.
What is EN 13795 High Performance? It is the higher of the two performance levels in the European standard EN 13795. In a gown’s critical area it requires at least 100 cm H₂O resistance to liquid penetration and a wet microbial barrier of 6.0 BI. Our SFS gowns are made from SFS65 fabric, which conforms to High Performance in the critical area.
Are your gowns AAMI Level 4? Our film-reinforced gowns meet the AAMI Level 4 liquid barrier standard in zones A, B and C. The Bodygard SFS Surgical Gown Level 4 is FDA 510(k) cleared as AAMI PB70 Level 4 (K221139).
What protection type is the coverall? PPE Category III, Type 5/6.
Are the drapes sterile? Yes. Felix Nonwovens surgical drapes are available in both sterile and non-sterile versions. The poly-tissue fenestrated drape is individually packaged and sterilised.
Can you make products under our brand? Yes. Contact us with your requirements.
Request a quote
Tell us the product, size and quantity. Phone: +90 222 236 23 63. Email: info@felixnonwovens.com. Or use the contact form.