Alhilal Healthcare Alhilal Healthcare

FDA 510 (K) AAMI PB70: 2012 Level-3 SMS Disposable Surgical Gown with Knitted Cuffs

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Product Description

📋 Basic Information
Model NO.
40083
Certification
FDA, ISO13485
Sterilization
Ethylene Oxide Sterilization
Application
Hospital, Operation Room, Dental Clinic
Group
Unisex
Color
Dark Blue
Level
Pb70:2012 Level-3
510(K) No.
K233183
Weight
45GSM
Style
Knitted Cuffs, Velcros Collar, Waist Ties
Transport Package
1PC/Bag, 40bags/Carton
Specification
XS-3XL
Origin
Hubei, China
🔍 Product Description
FDA 510 (K) AAMI PB70: 2012 Level-3 SMS Disposable Surgical Gown
  • Anti-bacterial & Water Resistance: Meets 510K level-3 requirements for superior protection.
  • Premium SMS Material: Wear-resistant, comfortable, and non-irritating to the skin.
  • Ergonomic Design: Features knitted wrists and a velcro back neck for easy adjustment and convenience.
  • Storage & Fit: Split design for convenient storage with customized sizing for a better fit.
  • High-Quality Construction: Ultrasonic heat-sealed seams ensure no burrs and a high-quality wearing experience.
Item SMS surgical (Premarket Submission Number: K233183)
Weight Per Square(g) 45g/m²
Hydrostatic Pressure (AATCC-127) > 50cm
Water Impact ≤1.0 g
Breaking Strength >20N
Tearing Strength >20N
Seam Strength >30N
Flammability Class I
EO Residue EO ≤ 4mg/d; ECH ≤ 9mg/d
Shelf Life 3 years
Protection Level Level 3 per AAMI PB 70
📦 Packaging & Shipping
Packaging 1pc/sterilized paper plastic bag, 40bags/carton (Adjustable per requirements)
Supply Capacity 50 Forty-Foot Containers per Month
Payment Terms L/C, D/A, D/P, T/T, Western Union, MoneyGram, Paypal, etc.
Shipping Ports Wuhan, Shanghai, Guangzhou, etc.
Sample Available upon request
Lead Time Peak time: 1-3 months; Off-peak: within 1 month
🖼️ Detailed Photos
💬 Frequently Asked Questions
Are you a factory or trading company?
We are both. This allows us to manufacture high-quality products while providing a comprehensive range of medical device solutions to meet all client needs.
Where is your production base located?
Our production facilities are located in the primary production hub for non-woven products in China, conveniently accessible for international visits.
How quickly can I receive a price quotation?
We typically provide quotes within 24 hours of receiving an inquiry. For urgent requests, please specify in your communication for priority handling.
Can I request a sample to evaluate quality?
Yes, after price confirmation, samples are available. We provide standard samples free of charge, with the client covering express freight costs.
What is the expected lead time for samples?
Samples are generally ready for delivery within 3-7 days and typically arrive via express within 3-5 working days.
What quality certifications do your products hold?
Quality is our priority. Our manufacturing processes and products have gained CE MDR, ISO, and FDA authentication to ensure international standards are met.

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