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Hospitals, research labs, and clean‑room operators in the USA need air that meets FDA, CE, and ISO‑9001 standards without inflating CAPEX. Our factory‑direct production guarantees up to 99.97% filtration efficiency at a price 20% lower than typical Chinese suppliers.
According to the American Hospital Association*, the average cost of a single nosocomial infection exceeds $30,000. Inadequate filtration is a primary driver.
US FDA 21 CFR Part 820 mandates HEPA‑grade air filtration for operating rooms. Failure leads to penalties and loss of accreditation.
Typical overseas vendors quote 45‑90 days. Our high‑speed delivery cuts that to 7‑15 days, keeping your projects on schedule.
| Parameter | Standard Model | Custom Options |
|---|---|---|
| Filtration Efficiency | ≥ 99.97% (0.3 µm) | ≥ 99.999% (0.1 µm) on request |
| Airflow Range | 100 – 5,000 CFM | 50 – 10,000 CFM |
| Operating Pressure Drop | ≤ 250 Pa | ≤ 300 Pa (custom) |
| Material | Glass‑Fiber Media, Stainless Steel Frame | Aluminum, Polypropylene Frames |
| Certifications | CE, FDA‑510(k), ISO‑9001, RoHS | Additional FCC, GS, CB on demand |
Operating Rooms – St. Mary’s Hospital (TX): Replaced legacy filters with our 2,500 CFM units, cutting airborne particle count by 87% and saving $45,000 annually on HVAC energy.
Pharmaceutical Cleanrooms – BioTech Labs (CA): Custom 1,200 CFM filter met ISO‑14644‑1 Class 5 requirements within 10 days, enabling a product launch two weeks early.
Research Laboratories – University of Michigan: OEM‑designed low‑profile filters reduced ceiling height requirements, freeing 12 % of lab floor space.
medical-air-filter medical-therapeutics-air-purifier
Dr. Laura Chen, Infection Control Director, St. Mary’s Hospital – “Since installing Lixin’s HEPA filters, our OR infection rate dropped from 3.2 % to 1.1 %. The ROI was realized in under six months.”
James Patel, Facility Manager, BioTech Labs – “Custom dimensions and a 7‑day delivery window saved us a critical project delay. Quality matched our EU‑based supplier standards.”
All filters are CE‑marked, FDA‑510(k) cleared, ISO 9001:2015 certified, and comply with RoHS, VDE, and US EPA air‑filter standards.
Yes. Our OEM/ODM service supports custom dimensions, frame materials, and media grades (up to Class 5 ISO‑14644‑1). Engineering drawings are provided within 3 business days.
Standard stock units ship in 7 days; custom‑spec units are produced and dispatched within 15 days after final design approval.
Absolutely. We provide a free 1‑unit sample with full test reports (efficiency, pressure drop, leakage). Shipping is on us to any US address.
Lifetime technical assistance, 2‑year warranty, on‑site replacement within 48 hours for any defective unit, and a dedicated account manager.

Only 50 free‑sample kits remain. Secure yours today and enjoy a risk‑free trial with a money‑back guarantee if performance does not meet specifications.
Or reach us instantly via WhatsApp +86 156 3318 3151 or email hebeilixin@hotmail.com.
Dr. Michael Reyes, Chief Surgeon – Cleveland Clinic
“Installation was seamless, and the filter’s pressure drop is negligible. Our post‑op infection rate fell by 2.1 % within the first quarter.”
Emily Wang, Procurement Lead – Kaiser Permanente
“The 10% discount and free sample saved us $12k on our pilot project. Delivery was on schedule, and the documentation met all audit requirements.”
Tomás Alvarez, Facility Engineer – Mayo Clinic
“Custom aluminum frames fit our tight ceiling clearance. Performance data matches the lab’s certification target perfectly.”
Linda Zhao, Ph.D. – Senior Technical Consultant, Hebei Lixin Medical Engineering. With 15 years of experience in clean‑room air‑handling systems and a background in biomedical engineering, Linda leads the OEM/ODM program for US hospitals. She has authored three peer‑reviewed papers on HEPA filter performance and regularly speaks at the International Society for Pharmaceutical Engineering (ISPE) conferences.
Contact Linda directly: linda.zhao@hblxmed.com