Company Overview

Zhejiang PerfectSeal New Material Technology Co., Ltd. is a high-tech enterprise specializing in the research, development, production, sales, and service of medical high polymer materials. The company focuses on acrylic and polypropylene medical polymers, producing medical masks, medical adhesives, melt-blown nonwoven fabrics, personal protective masks, industrial protective products, and other medical devices. PerfectSeal operates under the strict BSI ISO 13485:2016 medical device quality management system and maintains GMP-standard cleanrooms for production.

The company has advanced production lines, comprehensive testing equipment, and high-standard microbiological and physicochemical laboratories. It collaborates with Zhejiang University and Donghua University for research and development. The company philosophy emphasizes quality, sincere service, and health care, aiming to innovate continuously for human health.

Certifications and Compliance

• ISO 13485:2016 certification for medical device quality management.
• BSI 13485 medical device quality management system compliance.
• CE certification for products.
• Business license and medical device business record forms.
• Foreign trade record forms.

Factory Environment and Quality Control

Production occurs in GMP-standard cleanrooms with strict control over raw material selection, production processes, equipment management, quality inspection, packaging, and transportation. The company ensures that melt-blown fabric and mask products meet stringent customer requirements. The production strictly follows ISO 13485 quality management specifications.

Product Specifications

Melt-Blown Fabric

PerfectSeal produces various melt-blown fabrics primarily used in medical and protective masks. Key product models include PMF-99, PMF-90, PMF-95, PMV-90, PMP-90, and PMP-95, with specifications such as:

• Basis weight: 25g/m² ±2g
• Widths: 175mm or 260mm ±2mm
• Filtration Efficiency (PFE): ≥90% to ≥99% depending on model and flow rate
• Bacterial Filtration Efficiency (BFE): ≥95% to ≥99%
• Air resistance: ≤30Pa to ≤100Pa depending on flow rate

Features include uniform thickness, no surface defects, high filtration efficiency, low air resistance, odorless medical-grade raw materials (SGS certified), stable filtration under high temperature and humidity, high flexibility, and dense winding for stable mask machine operation. Custom weights (20g, 30g, 40g, 50g) and widths are available.

Mask Products

Disposable Face Masks: Three-layer protection with strong breathability, adjustable nose bridge, and filtration up to 95% of dust, bacteria, and pollen. Packaging typically 50 pieces per box, 40 boxes per carton.

N95 Series Masks: Five-layer filtration including non-woven fabric, hot air cotton, and melt-blown fabric layers. Features include:

• Effective filtration of particles ≥0.075 microns (both oily and non-oily)
• Earband or headband designs, some with breathing valves
• Activated carbon layers in some models for organic vapor and odor removal
• Adjustable invisible aluminum nose clips and soft sponge nose pads for comfort and fit
• Seamless ultrasonic welding for durability
• Aerodynamic breathing valves to reduce re-inhalation of exhaled air

Packaging varies by model, typically 20 pieces per box with multiple boxes per carton.

Disposable Gloves

Materials include nitrile and PVC, featuring superior strength, puncture resistance, food safety, high elasticity, and soft feel. Rolled rims facilitate easy donning. Available in various colors including white, blue, black, and transparent.

Hand Sanitizer Gel

Contains 75% alcohol with a unique formula for rapid and effective killing of bacteria, fungi, cocci, and viruses. It is gentle, non-irritating, and suitable for use in homes, offices, clinics, and schools. Packaging typically 1000 pieces per bottle, with cartons containing 100 bottles.

Packing and Logistics

Melt-Blown Fabric Packaging: Rolls typically weigh 6-12 kg depending on width, with lengths around 1400 meters. Packaging includes 2-4 rolls per carton with carton dimensions and weights specified. Container loading capacities for 20GP and 40GP containers are detailed, including volume, number of cartons, and net/gross weights.

Mask Packaging: Disposable masks and N95 masks are packed in boxes and cartons with specified quantities and carton dimensions to facilitate logistics.

Key Quality and Performance Parameters

• Filtration Efficiency (PFE and BFE) ranges from 90% to 99% depending on product type and test conditions.
• Air resistance values are maintained low to ensure breathability.
• Materials are medical-grade, odorless, and SGS certified.
• Products withstand high temperature and humidity with minimal loss in filtration efficiency.
• Mechanical properties such as tensile strength and elongation are optimized for production stability and user comfort.

Best Practices and Recommendations

• Strict adherence to ISO 13485 and GMP standards throughout production and quality control.
• Use of advanced testing and laboratory facilities to ensure product safety and performance.
• Customization options for melt-blown fabric weights and widths to meet diverse customer needs.
• Incorporation of ergonomic design features in masks for improved fit and comfort.
• Continuous innovation through collaboration with academic institutions.