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Surgical Drapes


It is composed of non-woven fabric or SMS material covered with PE film For surgical or emergency bedsheets, protective bedsheets Avoid surgical cross-infection Green or blue GMS 40-60 GSM, etc size 40x60cm, 50x70cm, 60x80cm With or without tape 1 piece/bag, 50 pieces/box Other sizes and packaging can be produced according to customer requirements

Regulatory CE MDR 2017/745 Standard
Quality ISO 13485 Certified System
Compliance FDA 510(k) US Market Cleared
Facility GMP Audit Production Safety
Sourcing Process
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Surgical Drapes — Kingphar Medical
Surgical Consumables · Single-Use
Surgical Drapes
SMS non-woven and PE film composite surgical drapes — EN 13795 High Performance compliant, sterile single-use, available in standard and custom configurations for hospital and institutional supply.
ISO 13485 CE MDR 2017/745 EN 13795 FDA Registered
40–60 GSM range
≥6.0 Barrier index (HP)
50 pcs Per box (standard)
Product Features
Why Kingphar Surgical Drapes
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EN 13795 High Performance Barrier
Bacterial barrier index ≥6.0 in critical zones — no detectable bacterial penetration. Meets the highest EN 13795-1 performance level for operating theatre use.
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SMS + PE Film Composite
Spunbond-Meltblown-Spunbond non-woven combined with PE film layer for superior liquid barrier protection. Soft, breathable, low linting.
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Sterile Single-Use
EO sterilized to SAL 10⁻⁶ — guaranteed sterility at point of use with validated ISO 11607 packaging. Individually bagged, 1 piece per peel-open sterile pack.
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Fluid & Cross-Infection Control
PE film layer provides liquid-proof barrier preventing blood and body fluid strike-through. Reduces surgical site infection risk and protects OR staff.
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Green or Blue — Optional Tape
Available in surgical green or surgical blue. With or without adhesive tape strip for securing to patient skin. All colors meet EN 13795 biocompatibility requirements.
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Standard & Custom Sizes
Standard sizes: 40×60cm, 50×70cm, 60×80cm. Custom dimensions, fenestrations, reinforced zones, and OEM packaging available on request.
Technical Specifications
Product Specification Reference
ParameterSpecificationNotes
MaterialSMS non-woven + PE film compositeSpunbond-Meltblown-Spunbond with polyethylene film laminate
Fabric weight (GSM)40–60 GSMStandard range; heavier GSM available for reinforced applications
Bacterial barrier (EN 13795)≥6.0 barrier index (High Performance)Critical zone — no detectable bacterial penetration under test conditions
Bioburden (pre-sterilization)≤300 CFU/dm²Per EN 13795-1 requirement — all areas
Colors availableSurgical green / surgical blueNon-toxic dyes, biocompatibility tested per ISO 10993
Standard sizes (unfolded)40×60cm / 50×70cm / 60×80cmOther sizes available per customer specification
Tape optionWith or without adhesive tape borderTape provides secure fixation to patient skin — specify at order stage
SterilizationEO (ethylene oxide) — ISO 11135SAL 10⁻⁶; aeration validated per ISO 10993-7
Packaging — primary1 piece per sterile peel-open pouchISO 11607 validated packaging — paper/film peel-open
Packaging — secondary50 pieces per box (standard)Custom quantities available for OEM orders
Shelf life3 years from sterilization dateStored in original sealed packaging, away from heat and direct light
Latex contentLatex-freeSafe for patients and staff with latex allergy protocols
RegulatoryCE (EU MDR 2017/745 Class IIa) · ISO 13485 · FDA registeredSFDA registration support available for GCC/Saudi Arabia supply
Custom specifications available
Kingphar produces surgical drapes in custom sizes, fenestration configurations, reinforced critical zone panels, and OEM private-label packaging. Minimum order quantities and lead times vary by specification — contact our team for a custom specification discussion.
EN 13795 Compliance
Understanding Performance Levels
Standard Performance
Bacterial Barrier Index ≥2.8
Critical zone BI ≥2.8
Suitable for procedures with limited anticipated fluid exposure — minor procedures, ENT, ophthalmology, peripheral draping zones. Not recommended for high-fluid surgical procedures.
✓ Kingphar Surgical Drapes — High Performance
Bacterial Barrier Index ≥6.0
Critical zone BI ≥6.0 — no detectable penetration
Required for cardiovascular surgery, orthopaedics, abdominal surgery, trauma, obstetrics, and any procedure with significant blood or irrigation fluid exposure. Recommended for all OR use by most hospital infection control policies.
What to request from any supplier
Always request the actual EN 13795-1 test report showing measured bacterial barrier index values — not just a certificate stating "EN 13795 compliant." Compliance at Standard Performance (BI ≥2.8) and High Performance (BI ≥6.0) are both "EN 13795 compliant" but provide very different clinical protection. Kingphar provides full EN 13795-1 test reports with every order. See our Surgical Drapes Specifications Guide for complete procurement guidance.
Clinical Applications
Indicated Uses
General surgery Abdominal procedures Cardiovascular surgery Orthopaedic surgery Caesarean section Urological procedures Emergency bedsheet Protective bedsheet ENT procedures Ophthalmology Trauma surgery Minor surgical procedures
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Custom sizes, fenestrations, and OEM packaging available
We produce to your exact specification — dimensions, reinforcement zones, apertures, private label packaging, and Arabic labeling for GCC supply.
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ISO 13485 · CE MDR 2017/745 Class IIa · EN 13795 High Performance · SFDA registration support for GCC markets

Frequently Asked Questions

Quick solution center of gravity

Pre-Purchase

  • We contronl everthing from the raw material to the finished product.Not only can reduce cost but also can grasp the quality
  • Aprofessional manufacturer of gauze, non-woven, cotton and mask  related products with more than 30 years experiences.
  • Customized production can be made according to customer requirements
  • Our certificate,product related all kinds of documents are complete,and do certification experience
  • We export over 100 countries like USA, GERMANY,POLAND,can gibe the xustomer certain reference opinion.
  • Our annual export can be up to CHINA TOP 10
  • Commerce department double white list
  • Professional OEM manufacturer for 30 years First 500 China National Business Credit Enterprises Market covers over 60 countries and regions Service available 24*7,solve your problem at any time

We can provide OEM/ODM services. We have a professional design and production team, that can
produce according to your requirements.

Please contact our custom service to advise your detail request,we will offer some sample for free,
you only need to pay the postage charge. If you already play orders,we will send free samples by our account

Always a pre-production sample before mass production;
Always final Inspection before shipment;

Post-Purchase

We accept FOB, CIF, etc. You can choose the one which is the most convenient or cost effective for you.

Normally 5 day after receiving your payment, but it can be negotiated based on order quantity.

We work with TNT, FedEX, UPS, EMS, DHL to supply you with the best, fastest and safest courier services. It will take about
3-10 days.

Step 1: Confirm the order details (design/art-work, material, quantity, size etc)
Step 2: Pay the deposit
Step 3: Start production
Step 4: Finish production and quality checking
Step 5: Arrange the balance
Step 6:Ship out goods and provide tracking number
Step 7: Receive the goods
Step 8: Give feedback (in order to improve our production and service)

We ensure the quality of the products, and in case of misfortune, we will replace the defective products free of charge according to the quantity of the order

Size

40x60cm, 50x70cm, 60x80cm