Grade Protection, Safety First – Your Professional Medical Protection Partner!
Our CNAS certified R&D center and laboratory are equipped with international advanced testing equipment, ensuring all performance indicators of AAMI 1-4 series isolation gowns fully meet American standards.
Our skilled workers with decades of medical protection production experience, and provide one-to-one customized OEM/ODM services, to meet the diverse protection needs of global medical institutions, laboratories and medical workers.
Grade Protection, Safety First – Your Professional Medical Protection Partner!
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Our CNAS certified R&D center and laboratory are equipped with international advanced testing equipment, ensuring all performance indicators of AAMI 1-4 series isolation gowns fully meet American standards.
Our skilled workers with decades of medical protection production experience, and provide one-to-one customized
OEM/ODM services,to meet the diverse protection needs of global medical institutions, laboratories and medical workers.
AAMI Standard Material Inspection
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The core of AAMI series isolation gowns is liquid barrier performance, our professional R&D center carries out full-item strict testing on each batch of fabrics, and only puts them into production after passing the test, with CNAS certified testing data and traceable whole process.
Key Test Projects (in accordance with AAMI PB70/ASTM standards)
Liquid barrier test
Impact penetration test (AATCC 42), hydrostatic pressure test (AATCC 127), blood/virus penetration test (ASTM F1671/F1671M)
Physical performance test
Tensile strength test (D5034) ≥30N, tear strength test (D5587/D5733) ≥10N, seam strength test (D1683/D1683M) ≥30N
Professional equipment
Gas Chromatograph, Water Permeability Tester, Fabric Friction Tester, Tensile Testing Machine
Data management
All test data are recorded and archived in detail, forming a batch material inspection report to ensure compliance with AAMI Level 1-4 index requirements.
Precision Cutting (AAMI Standard Version Design)
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Adopt CNC automatic cutting bed + laser cutting technology, cutting precision ±1mm, fully in accordance with AAMI PB70 standard 360° coverage design requirements, the isolation gown is cut into chest, back, arms, cuffs, waist and other functional parts.
AAMI Level 2 Isolation Gown – Production Process & Machinery
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Fully compliant with AAMI PB70 Level 2 | Waterproof & Liquid Barrier | Stable Mass Production
Ultrasonic Welding Machine – Main Body Sealing
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Our AAMI Level 2 isolation gown adopts full ultrasonic thermal bonding technology to replace traditional needle stitching, ensuring zero needle-hole leakage and stable barrier performance.
High-frequency vibration fuses nonwoven layers tightly without thread, glue or staples
Forms smooth, strong, airtight seams that meet AAMI Level 2 fluid resistance
Automatic continuous sealing for side seams, shoulder seams and key protection areas
High efficiency, consistent quality, suitable for large‑scale medical production
Waist Spot Welding Machine – Waist Belt Fixing
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The waist belt / waist tie is firmly fixed by a dedicated ultrasonic spot welding machine to ensure strong, non‑detachable joints during wear.
Precise spot welding at fixed positions for uniform tension
High bonding strength, not easy to tear or fall off
Clean, lint‑free, suitable for medical cleanroom standards
Fast, stable, supports high‑volume continuous production
Cuff Process – Elastic Thumb Loop Cuff or Knit Cuff
We provide two professional cuff systems for AAMI Level 2 isolation gowns, both produced by automatic cuff‑forming machinery.
Option A:Elastic Thumb Loop Cuff
High‑elastic soft rubber band integrated by automatic cuff machine
Built‑in thumb loop to prevent sleeve sliding and expose wrist
Comfortable fit, easy to wear with medical gloves
Maintain sterile barrier during operation
Option B: Knit Cuff
Soft, breathable, stretchable medical knitted cuff
Automatic sewing/thermal bonding for firm connection
Snug fit, skin‑friendly, latex‑free optional
Widely used in hospitals, clinics and healthcare scenarios
FG Final Inspection (AAMI Standard Compliance Confirmation)
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Before ex-factory delivery, carry out the final comprehensive inspection of the whole batch of products, focusing on confirming the compliance of AAMI standard and the consistency of batch quality:
- Sample inspection: Random sampling according to the AQL 4.0 standard specified by AAMI PB70, and carry out the re-inspection of liquid barrier performance and physical performance;
- Packaging confirmation: Check the consistency of inner and outer packaging labels, the integrity of packaging and the correctness of AAMI grade marking;
- Document sorting: For each batch of products, issue a factory inspection report, including material inspection data, finished product test results, AAMI standard compliance certificate and other complete documents;
Only the products that pass all the final inspection items can obtain the ex-factory qualification and enter the subsequent loading and transportation link.
Carton Packing & Boxing
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After vacuum sealing, products enter the automatic carton packing line for final boxing and pallet preparation.
Standardized carton packaging with clear labeling: size, quantity, AAMI Level 2, batch number, production date
Neat stacking, anti‑pressure and anti‑collision design to protect products during transit
Fully compatible with sea/air logistics and global customs clearance requirements
Supports customized labeling, logo printing, and export‑standard outer packaging
Container Loading – Safe Transit for Global Delivery
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After vacuum packing and carton boxing, our AAMI Level 2 isolation gowns enter the standardized container loading process, ensuring the products remain intact, sterile, and compliant during long-distance sea, air, or land transportation-critical for global medical distributors and importers.
OEM & Bulk AAMI Isolation Gowns Manufacturing Partner You Can Rely On
HIKNUO is an experienced professional manufacturer of AAMI PB70 standard disposable isolation gowns, specializing in bulk and long-term supply for global medical device distributors, importers, hospitals and institutional buyers.
We are equipped with:
- Certified manufacturing systems fully compliant with AAMI PB70, FDA, CE, EN13795 medical standards;
- Stable and scalable production capacity, supporting large-volume orders of AAMI Level 1-4 isolation gowns, with short delivery cycle;
- Dedicated OEM/ODM production lines, supporting customization of fabric, style, protection level and packaging;
- Strict batch quality control, complete document records, and consistent product quality across batches.
From sample development, material customization to mass production, our professional R&D and production team provides one-stop solutions with clear AAMI standard specifications, reliable lead times and transparent manufacturing processes.
Request an OEM quotation or bulk pricing for AAMI Level 1-4 isolation gowns today.
Our manufacturing team is ready to support your medical protection project with professional AAMI standard solutions!