UniSeal ® - Solutions at Hand

Sterile Latex Surgical,
Low Protein Gloves

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UniSeal® Sensiflex® Gloves provide superior protection, high tactile sensitivity, and unparalleled comfort. Sterilized under the most stringent irradiation guidelines, these gloves ensure safety and cleanliness to patients and medical professionals.

Type: Sterile Surgical Glove
Shape: Anatomic

   – Features
    • Textured Finish
    • Sterilized by gamma
    irradiation
   • Consistent and reliable
    quality
   • Low modulus compound for
    maximum softness and
    comfort
   • Bar-coded boxes and cartons
   • Dated Lot Codes for quality
    assurance and traceability
   • Safety Sealed Packaging
   • 50 Pair/Box, 4 Boxes/Case
   • 1 Case = 1.198 Cubic Feet

   – Dimensions/Sizes
   – Quality Standard
   – Manufacturing Standard
   – Physical Properties

Ingredients: 100% Natural Rubber Latex concentrated and compounded with specification or fomulation for high flexibility.

Testing Method: RRIM Modified Lowry Microassay Test with precipitation of proteins using Trichloroacetic and Phosphotungstic acids or ASTM Standard Test Method D5712-95

Protein Level: Total protein content is 50 µg/g or less of total extractable protein, using modified Lowry assay for measuring total protein*

Dimensions (all measurements in mm)
Sizes	Item #	Glove Length	Palm width +/-10mm	Thickness
Sizes	Item #	Glove Length	Palm width +/-10mm	Cuff	Palm	Finger
5 1/2	030-5.5	300	70	0.14	0.16	0.18
6	030-6.0	300	76	0.14	0.16	0.18
6 1/2	030-6.5	300	83	0.14	0.16	0.18
7	030-7.0	300	89	0.14	0.16	0.18
7 1/2	030-7.5	300	95	0.14	0.16	0.18
8	030-8.0	300	102	0.14	0.16	0.18
8 1/2	030-8.5	300	108	0.14	0.16	0.18
9	030-9.0	300	114	0.14	0.16	0.18

Quality Standards

• Meets or exceeds the following standards: ASTM D3577-91 (USA), EN 455 (EEC), AS 40 (Australia), JIS T 9107, SABS 1155, FDA, CE
• Quality sampled in accordance with MIL.STD 105D
• ISO 9002 Certified Manufacturing
• Meets the Viral Penetration Test (ASTM F1671-97)
• Passes 200 Modified Human Draize Skin Allergy Test

Manufacturing Standards
• Brand new state-of-the-art manufacturing plant with computer-controller market-leading technology.
Defect	Inspection Level	AQL
Pinholes (FDA 1000ml watertight test)	Level 11	1.5
Visual Defects (major)	S-4	1.5
Visual Defects (minor)	S-4	2.5
Dimensions	S-2	4.0

Physical Properties
Before Aging:		Accelerated Aging: 7 days @ 70°C

UniSeal® Tensile Strength (Mpa) ASTM Minimum Requirement

Physical Properties
Before Aging:		Accelerated Aging: 7 days @ 70°C

UniSeal® Ultimate Elongation ASTM Minimum Requirement

*No sensitizing threshold. Any individual with proven hypersensitivity to natural rubber latex should consult a physician before using any latex product.

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