What AAMI level do I need for a surgical gown?

Level 3 is the minimum for moderate fluid exposure in surgery. Level 4 is required for high-risk procedures with known pathogen exposure. The exact level is specified by your hospital or device regulator. We supply SMMS 45-60 GSM for Level 3, and SMMS 60-70 GSM or film laminate for Level 4, with ASTM F1671 test data.

Can Olefins provide fabric for EO or gamma sterilisation?

Yes. Our SMS and SMMS fabrics are compatible with ethylene oxide (EO) and gamma irradiation sterilisation. We provide post-sterilisation test data on request to support your sterile barrier system validation.

Do you hold ISO 13485 certification?

Olefins is ISO 9001:2015 certified for quality management. We do not hold ISO 13485. We supply fabric with full lot-level test data — GSM, tensile, hydrostatic head, and ASTM F1670 — for your garment-level ISO 13485 or FDA 510k submission.

What is the difference between AAMI PB70 and EN 13795?

AAMI PB70 is the US standard that defines barrier levels 1-4 based on water resistance and blood penetration. EN 13795 is the European standard for surgical gowns and drapes, with 'Standard' and 'High Performance' classifications. The test methods overlap. We supply data for both standards on request.

Medical-Grade SMS & SMMS Nonwoven Fabric — Engineered for Healthcare Environments

Olefins Private Limited manufactures medical-grade SMS and SMMS nonwoven fabrics that meet the barrier, sterility, and biocompatibility requirements of global healthcare product manufacturers. From Level 1 isolation gowns to Level 3 surgical drapes, our medical fabrics deliver the performance your products and your patients demand.

Medical Fabric Products

Product	GSM Range	AAMI Level	Hydrostatic Head (AATCC 127)	Key Applications
SMS — Light Medical	25-45 GSM	Level 1-2	L2: ≥20 cm H₂O	Isolation gowns, surgical caps, shoe covers
SMMS — Standard Medical (Surgical Gowns)	35-55 GSM	Level 2-3	L3: ≥50 cm H₂O	Surgical gowns, drapes, sterile wraps
SMMS — High Barrier	40-60 GSM	Level 3-4	≥50 cm H₂O + Blood/Viral barrier for L4	High-fluid surgical gowns, Type 5/6 PPE Coveralls
Spunbond — PPE Components	20-30 GSM	Base layer	Spray Rating ≥3 (ISO 4920)	Face mask layers, medical caps, coverall lining

SMS (S-M-S) is a three-layer construction and SMMS (S-M-M-S) adds a second meltblown layer for higher barrier uniformity at the same GSM. Specify SMS for Level 1-2 isolation and SMMS for Level 3 surgical gowns where ≥50 cm H2O is required — see our full SMS vs SMMS difference guide for specs, hydrostatic head and cost. For full GSM specifications across hygiene, medical and PPE applications, see GSM Nonwoven Fabric Guide.

For a technical comparison of fabric constructions, see our spunbond vs spunmelt guide.

Compliance & Standards

AAMI PB70 Barrier Levels and Matching Fabric Specification

AAMI Level	Typical Application	Construction	GSM	Hydrostatic Head
Level 1	Visitor gowns, basic isolation, minimal fluid risk	Spunbond or light SMS	20-35	Low
Level 2	Isolation gowns, low-fluid procedures, blood draw	SMS	35-45	>20 cm H2O
Level 3	Surgical gowns, arthroscopy, moderate fluid exposure	SMMS	45-60	>50 cm H2O
Level 4	Critical zones, high fluid and pathogen exposure	SMMS or film laminate	60-70	Requires ASTM F1671 pass

Barrier level is a property of the finished garment, not the fabric alone. Olefins supplies fabric with the test data needed to support your garment certification.

Certification & Documentation

Olefins supplies medical-grade nonwoven fabric with full lot-level test documentation covering GSM (ISO 9073-1), tensile strength (ISO 9073-3), hydrostatic head (EN 20811) and synthetic blood penetration resistance (ASTM F1670). We provide complete test reports and material safety data sheets with every order to support your garment-level AAMI PB70, EN 13795, or FDA 510k submission. Full detail is in our guide to medical nonwoven fabric certifications.

Medical Nonwoven Fabric — Frequently Asked Questions

What AAMI level do I need for a surgical gown?: Level 3 is the minimum for moderate fluid exposure in surgery. Level 4 is required for high-risk procedures with known pathogen exposure. The exact level is specified by your hospital or device regulator. We supply SMMS 45-60 GSM for Level 3, and SMMS 60-70 GSM or film laminate for Level 4, with ASTM F1671 test data.
Can Olefins provide fabric for EO or gamma sterilisation?: Yes. Our SMS and SMMS fabrics are compatible with ethylene oxide (EO) and gamma irradiation sterilisation. We provide post-sterilisation test data on request to support your sterile barrier system validation.
Do you hold ISO 13485 certification?: Olefins is ISO 9001:2015 certified for quality management. We do not hold ISO 13485. We supply fabric with full lot-level test data — GSM, tensile, hydrostatic head, and ASTM F1670 — for your garment-level ISO 13485 or FDA 510k submission.
What is the difference between AAMI PB70 and EN 13795?: AAMI PB70 is the US standard that defines barrier levels 1-4 based on water resistance and blood penetration. EN 13795 is the European standard for surgical gowns and drapes, with "Standard" and "High Performance" classifications. The test methods overlap. We supply data for both standards on request.

Medical Nonwoven Fabric Manufacturing: Cleanroom to Converting

Olefins medical fabrics are manufactured in ISO Class 8 cleanroom-equivalent environments to prevent particulate contamination. Our Reicofil 4S lines use dedicated polymer handling systems for medical grades — no cross-contamination with industrial or hygiene lines.

1. Raw Material Selection & Traceability

We use only FDA-compliant virgin polypropylene resins from ExxonMobil and LyondellBasell. Every batch includes USP Class VI biocompatibility certification and DMF letters for FDA 510(k) submissions. Full lot traceability is maintained from polymer pellet to finished roll — critical for medical device manufacturers facing FDA audits. Resin certificates, migration test data, and irradiation stability reports are provided with each shipment.

2. Sterilization Compatibility Testing

Our SMMS medical fabrics are validated for Ethylene Oxide (EO), Gamma irradiation at 25-50 kGy, and E-beam sterilization. Post-sterilization testing confirms no degradation in tensile strength, elongation, or barrier performance. We provide sterilization validation reports per ISO 11135 and ISO 11137 standards. This data supports your device master file and reduces your qualification timeline by 6-8 weeks.

3. In-Line Quality Control & Lab Testing

Every master roll undergoes 100% in-line testing for GSM uniformity using beta-gauge, pinhole detection via light table inspection, and barrier testing. Our in-house lab performs AAMI PB70 hydrostatic head testing, ASTM F1670 synthetic blood penetration, and EN 13795 microbial penetration resistance, maintaining full compliance with global medical nonwoven certifications. Test reports with actual values — not ranges — accompany every lot. We retain samples for 5 years for regulatory traceability.

Choosing the Right Medical Fabric for Your Application

Selecting fabric for medical devices requires balancing barrier performance, breathability, comfort, and cost. Read our specialized guide on surgical gown and drape fabric selection. Wrong selection leads to failed biocompatibility tests or uncomfortable end-products.

Application	Recommended Fabric	Why This Spec
Surgical Gowns — Level 3	SMMS 45-60 GSM, Alcohol Repellent	Hydrostatic head >50 cm H2O, passes ASTM F1671 viral penetration
Surgical Drapes	SMMS 50-60 GSM + Film Laminate	Impervious barrier in critical zone, breathable in non-critical areas
Face Mask Outer Layer	Spunbond 25-30 GSM, Hydrophobic (face mask nonwoven layers)	Fluid resistance + low pressure drop for breathability
PPE Coveralls	SMS 50-65 GSM, Antistatic	Type 5/6 protection, comfortable for 8-hour shifts
Sterilization Wrap	SMMS 60-70 GSM, High Porosity	Allows EO/gamma penetration, maintains sterility for 6 months

Unsure which AAMI level or construction your product needs? Our technical team provides free specification matching based on your target standard — AAMI PB70, EN 13795, or China YY/T 0506. Send us your competitor sample or device requirements for a direct comparison report.