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Surgical Kits


The surgical kit contains: A tray 6 cotton balls (0.5g/piece) 5 gauze sheets (7.5cmx7.5cm-8 layers) Two tweezers A towel 1 tarp 1 wrapping paper Other sizes and packaging can be produced according to customers

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 Consumables · Surgical Kits

Surgical Kits & Custom Procedure Packs:
Sterile, Cleanroom-Assembled, Fully Customizable

Pre-assembled sterile dressing kits and fully custom procedure packs — from basic wound care sets to complex specialty configurations. ISO 13485 certified, ISO 11607 compliant packaging, 10,000-grade cleanroom assembly, EO sterilized.

Assembly
ISO 7 Cleanroom
10,000-grade HEPA-filtered
Sterilization
EO / Steam
ISO 11135 / ISO 17665 validated
Packaging
ISO 11607
CE MDR + FDA recognized
Product Features

Each feature addresses a specific procurement requirement — from sterile assurance to supply chain efficiency.

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10,000-Grade Cleanroom Assembly
All kits assembled in ISO Class 7 cleanroom with HEPA filtration, positive pressure, and full gowning protocol. Ensures pre-sterilization bioburden is controlled for consistent SAL 10⁻⁶ achievement.
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Custom Bill of Materials
Configure exact components per your hospital protocol or surgeon preference card. From 7-component basic dressing kits to 50+ component specialty packs — every BOM is locked after clinical validation.
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ISO 11607 Sterile Packaging
Packaging validated per ISO 11607-1 (materials & SBS) and ISO 11607-2 (process IQ/OQ/PQ). Paper/film, blister tray, or SMS wrap formats. Accelerated aging tested per ASTM F1980 for 3–5 year shelf life.
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Batch-Level Documentation
Every shipment includes Certificate of Conformity, sterilization batch records with BI results, component lot traceability, and numeric test values — ready for institutional QA acceptance and tender submission.
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GCC & Global Regulatory Support
CE MDR 2017/745 compliant, FDA registered facility. SFDA classification support, Arabic bilingual labeling, and Halal certification documentation for Saudi Arabia and wider GCC institutional tenders.
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Waste & Cost Optimization
Custom-configured packs eliminate unused components that drive up per-case waste. Published evidence shows optimized packs can reduce consumable cost per case by ~50% and cut annual surgical waste by thousands of pounds.
Kit Type → Clinical Scenario Matching

Select the kit tier that matches your clinical workflow and procurement volume.

Kit TypeComponentsTypical UseSterilizationMOQ Range
Basic Dressing Kit 7–10 items: tray, gauze, cotton balls, forceps, drape, towel, wrap Ward wound care, outpatient dressing changes, ED wound management EO 5,000–10,000
Minor Procedure Pack 10–20 items: above + scalpel, scissors, adhesive drape, extra swab sizes, skin marker Day-surgery, suturing, suture removal, wound debridement EO 5,000–15,000
Specialty Procedure Pack 20–100+ items: drapes, gowns, instruments, specialty consumables per procedure type OR — general, orthopedic, obstetric, urologic, cardiac procedures EO or Gamma 10,000–20,000
Exam / Diagnostic Kit 5–12 items: gloves, swabs, tongue depressor, specimen container, drape Clinical examination, specimen collection, diagnostic prep EO 5,000–10,000
Standard Dressing Kit — Full Specification
ParameterSpecification
TrayPlastic integral gallipot tray, single-use
Cotton balls6 pcs × 0.5 g, absorbent cotton BP/USP
Gauze sheets5 pcs × 7.5 cm × 7.5 cm, 8-ply, woven cotton
Forceps2 pcs, plastic disposable (metal upgrade available)
Towel1 pc, non-woven or cotton-blend absorbent
Drape1 pc, non-woven, fluid-resistant
WrappingMedical-grade crepe or SMS wrap
SterilizationEO sterilized per ISO 11135
PackagingPaper/film pouch or blister pack, ISO 11607 compliant
Shelf life3–5 years (accelerated aging per ASTM F1980)
CertificationsISO 13485, CE MDR 2017/745, FDA registered
LabelingEnglish standard; Arabic, French, Spanish, German, Russian available
Application Scenarios
Hospital Ward Wound Care Emergency Department Outpatient Clinics Day Surgery Centers Operating Room Setup Surgical Site Prep Post-Operative Dressing Clinical Examination Home Nursing Kits Dental Procedure Trays Obstetric Delivery Packs Orthopedic Procedure Packs

OEM Customization Options

Component Configuration
Specify exact items, materials, sizes, and quantities per kit. Add or remove components to match hospital formulary or surgeon preference cards.
Packaging Format
Paper/film pouch, blister tray with Tyvek lid, SMS wrap, or combination. Custom print with hospital logo, color coding by kit type, and barcode/RFID integration.
Labeling & Language
Private label with your brand. Bilingual or multilingual IFU. Arabic labeling for SFDA/GCC. UDI-compliant labeling per EU MDR and FDA requirements.
Sterilization & Shelf Life
EO, steam, or gamma — selected per component compatibility. Shelf-life validation to 3 or 5 years with accelerated aging data package included.

Request Surgical Kit Samples or Custom Pack Quotation

Standard dressing kits and fully custom procedure packs — ISO 13485, ISO 11607, CE MDR, FDA registered. SFDA support and Arabic labeling for GCC markets.

Keywords:Surgical Kits

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

Tray

1

Cotton Balls

6 (0.5g/Piece)

Gauze Sheets

5 (7.5 cm x 7.5 cm-8 Layers)

Tweezers

2

Towel

1

Wrapping paper

1