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Gauze Ball

100% cotton, in line with USP 17 and 20 gauze tape/without X-ray, round, flat or cap-shaped sterile or non-sterilized unfolded size: 10cmx10cm 15cmx16cm ZOcmx20cm25cmx26cm 30cmx30cm 30cmx40cm40cmx50cm Other sizes and packaging can be based on customers Requires the production of medical absorbent cotton 1 traits Medical absorbent cotton should be soft and elastic white fiber, without stains, stains and foreign matter, odorless and tasteless. 2 Whiteness The whiteness of medical absorbent cotton should not be less than 80

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 · Cotton Gauze Series

Gauze Ball
Cotton Spheres, X-Ray Detectable Options

100% cotton compressed gauze balls for surgical, ENT, ophthalmic, dental, and wound care applications. Diameters from 10mm to 50mm. Sterile peel-pouch or bulk non-sterile packaging. OEM customization available with CE, FDA, and SFDA documentation.

Diameter Range
10–50mm
8 standard sizes
Cotton
100%
USP Type VII bleached
BaSO₄ Thread
≥55%
X-ray detectable variant
Product Features

Engineered for Surgical & Clinical Use

Every Kingphar gauze ball is constructed from oxygen-bleached, USP Type VII woven cotton, mechanically compressed into a stable, low-lint sphere. Standard and customized configurations available.

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100% Cotton Construction

Premium combed cotton yarn, oxygen-bleached (hydrogen peroxide), no fluorescent whitening agents, pH neutral, biocompatible per ISO 10993.

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X-Ray Detectable Option

Blue polypropylene thread with BaSO₄ ≥55%, woven through the gauze structure. EN 14079 compliant. Available across all standard sizes.

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Low-Lint Compression

Mechanically compressed manufacturing process produces minimal loose fibres. Edge-sealed construction prevents fragmentation during use.

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Sterile or Non-Sterile

Sterile peel-pouches (5/10/25 per pouch) by EO or gamma, or bulk non-sterile bags (100g/500g/1000g) for on-site sterilization.

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Optional Ring Attachment

Elastic or silicone ring attachment for deep cavity procedures, preventing accidental gauze loss into the operative field.

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Full Documentation

ISO 13485 certified manufacture, CE Mark under EU MDR 2017/745, FDA 510(k) cleared, SFDA registered for GCC markets.

Size Selection

Eight Standard Diameters

Select by clinical specialty and absorbency requirement. Custom sizes available on request with minimum order quantity.

10mm
~0.3g · 4-ply
Ophthalmic
15mm
~0.5g · 4-ply
ENT / Dental
20mm
~0.7g · 4-ply
Minor Surgery
25mm
~1.0g · 4-ply
General OR
30mm
~1.2g · 4–6 ply
General OR
40mm
~1.6g · 4–8 ply
Gynae / Ortho
45mm
~1.9g · 4–8 ply
Cavity Packing
50mm
~2.2g · 4–8 ply
Trauma / Cavity
Technical Specifications

Complete Specification Sheet

Parameter Standard Specification
Material100% bleached cotton (USP Type VII)
Diameter range10mm, 15mm, 20mm, 25mm, 30mm, 40mm, 45mm, 50mm
Weight (per piece)0.3g – 2.2g (size-dependent)
Ply4-ply standard; 6-ply and 8-ply available
Mesh density9–22 threads/inch (13–17 most common)
Yarn count21s/21s, 32s/32s, 40s/40s
X-ray threadPolypropylene + BaSO₄ ≥55%, blue colour
Bleaching methodHydrogen peroxide (oxygen bleaching)
pH5.0 – 7.5
Fluorescent agentsNone (FWA-free)
SterilizationEO (Ethylene Oxide) or Gamma (Co-60)
Sterile pouch options5, 10, 25 pcs per peel-pouch
Non-sterile bulk options100g, 500g, 1000g per bag
Shelf life3 – 5 years from manufacture date
Optional featuresElastic ring, silicone ring, colour cotton (green / blue), shaped variants (peanut, triangular)
Clinical Applications

Multi-Specialty Use Cases

Gauze balls serve absorption, packing, prep, and cleansing functions across virtually every surgical specialty.

ENT Surgery Ophthalmic Surgery Dental & Oral Surgery General Surgery Gynaecology Orthopaedic Surgery Trauma & Emergency Skin Antisepsis Wound Cleansing Cavity Packing Veterinary Surgery Cosmetic Procedures

OEM & Private Label

Full customization from 50,000 pieces. Lead time 30–60 days inclusive of sterilization cycle. All shipments include LOT-specific compliance documentation.

  • Diameter to ±0.5mm tolerance
  • Custom mesh, yarn count, ply
  • X-ray thread inclusion or omission
  • Optional ring (elastic / silicone)
  • Pouch count (5 / 10 / 25 per pouch)
  • Private-label pouch & carton printing
  • Sterilization election (EO or gamma)
  • Custom shelf-life dating
Certifications & Standards

Compliance Documentation

All gauze ball SKUs are manufactured under ISO 13485 QMS, with LOT-specific test reports available for every shipment.

ISO 13485
CE Mark (MDR 2017/745)
FDA 510(k)
SFDA Registered
DIN EN 14079
USP Type VII
BP Standard
ISO 10993 Biocompatibility
ISO 11135 / 11137

Ready to Source Gauze Balls?

Request samples, technical datasheets, and a tailored quotation. Standard SKUs ship from 5,000 pieces; OEM customization from 50,000 pieces with full CE / FDA / SFDA documentation.

made for

Expanded size

10x10cm, 15x16cm, 20x20cm, 25x26cm, 30x30cm