Medical Specimen Bags, Double-Layer Leak-Proof, External Document Pouch Design

Core Selling Points

Innovative Double-Layer Leak-Proof Technology: Using patented double-layer sealing structure, forming a 0.5mm safety buffer zone between inner and outer layers, even if the inner layer is damaged it can still prevent liquid leakage, seal integrity testing pass rate reaching 99.9%, improving safety factor by 85% compared to single-layer designs.
Carefully Designed External Document Pouch: Unique external document pouch measuring 4.5×6 inches, made of waterproof material, can store medical history summaries, test application forms, and other A6-sized documents, physically isolating documents from specimens, reducing sample information mismatch rate to below 0.01%.
Medical-Grade Material Guarantee: Using food-grade LDPE+HDPE composite material, thickness reaching 3.5 MIL, passing ISO 10993-5 biocompatibility testing with no cytotoxicity, transparency up to 93%, facilitating observation of specimen color, precipitation, and other characteristics.
Excellent Mechanical Performance: Puncture resistance strength reaching 8.8N, tear resistance strength 12.5N, can withstand extreme temperature environments from -40℃ to 80℃, particularly suitable for various refrigerated and frozen specimens and chemically fixed specimens storage and transport.
Strictly Compliant with International Standards: Design complies with CAP (College of American Pathologists) and CLIA laboratory standards, passed FDA 510(k) certification and ISO 13485 quality management system certification, meeting medical laboratory accreditation criteria requirements.

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Material and Process Details

This product uses medical-grade low-density polyethylene (LDPE) and high-density polyethylene (HDPE) composite materials, formed through double-layer co-extrusion in one molding, ensuring interlayer bonding strength of 4.2N/cm. The inner layer uses LDPE material, high softness, good affinity with liquid samples, low permeability at 0.01g/m²·24h; the outer layer uses HDPE material, providing excellent mechanical strength and barrier properties. Thickness uniformity controlled within ±0.08 MIL range, ensuring consistent and reliable protection performance. The external document pouch undergoes special coating treatment, water resistance reaching 72 hours, good anti-ink permeability, writing with medical markers doesn't smudge. The sealing area uses ultrasonic molecular bonding technology, seam strength 60% higher than traditional heat sealing, maintaining good sealing performance even in -40℃ low-temperature environments. All materials are free from phthalates (DEHP), bisphenol A (BPA), and other harmful substances, complying with EU REACH regulation requirements.

Application Scenarios

Hospital Laboratory Department: Processing 800+ routine specimens such as blood, urine, sputum daily, double-layer leak-proof design effectively preventing high-infectivity specimen leakage, external document pouch holding test application forms, specimen information accuracy improved to 99.99%, work efficiency increased by 42%.
Pathology Department Tissue Sample Management: Used for storing tissue sections, biopsy specimens, and other precious samples, 93% transparency material facilitating observation of tissue color and morphology, double-layer protection ensuring fixatives such as formalin won't leak, reducing harmful gas evaporation by 85%, protecting staff health.
Microbiology Laboratory: Processing 300+ microbial cultures weekly, 8.8N puncture resistance strength material ensuring sharp objects won't pierce the bag, effectively isolating potential pathogens, laboratory-acquired infection risk reduced by 92%, improving biosafety level.
Multi-Center Clinical Research Sample Transport: Sample transport between medical research centers 500+ times monthly, standardized external document pouch design ensuring synchronized tracking of research data and samples, sample traceability reaching 100%, research data quality significantly improved.

Usage Steps

Bag Preparation: Take the medical specimen bag from the sealed packaging, check that the double-layer structure and external document pouch are intact, gently unfold the bag, ensuring no wrinkles and adhesion.
Document Placement: Place specimen-related documents (such as medical history summaries, test application forms) into the external document pouch, ensuring documents are fully inserted and flat, facilitating information identification.
Specimen Loading: Confirm specimen containers (such as blood collection tubes, urine cups) are well sealed before placing into the main bag, handle gently, avoid squeezing, it is recommended to place only one specimen in a single bag.
Information Verification: After placing the specimen, verify that the information in the external document pouch matches the specimen number, ensuring accurate matching of specimens and information, reducing confusion risk.
Sealing Storage: Complete sealing according to the specimen bag design type (such as adhesive strip sealing or self-sealing closure), ensure complete sealing, without bubbles and gaps, mark storage conditions (such as refrigeration, freezing) before proper storage.

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Maintenance Guide

Storage Conditions: Should be stored in temperature 10-30℃, relative humidity 30%-70% environments, avoid direct sunlight and humid environments, away from heat sources and chemical reagents, preventing material aging and deterioration.
Usage Period: Unopened products have a shelf life of 36 months under appropriate conditions, after opening it is recommended to use within 12 months, products exceeding this period may risk decreased sealing performance.
Batch Management: Laboratories should establish specimen bag usage records, recording batch numbers and usage dates, implementing first-in-first-out principle, avoiding performance changes due to long-term storage.
Quality Testing: At least 3% of inventory specimen bags should be sampled quarterly for sealing testing (injecting 10ml water, sealing for 24 hours) and document pouch waterproof testing, promptly replacing batches if abnormalities are found.
Low-Temperature Usage Precautions: Before use in freezing environments (below -20℃), should be placed at room temperature for 15 minutes to restore material flexibility, preventing low-temperature embrittlement leading to sealing failure or bag damage.