Nitrile Gloves, VIOLET, Powder-Free, 1 CARTON
Available as
Packaging: 100 gloves per box; 10 boxes per carton (1,000 gloves/carton),
Available sizes:
S/M/L/XL
Product: Powder-Free Examination Gloves
Material: 100%
Type: Disposable, Powder-Free, Latex-Free
Thickness: Minimum 4.0 mil palm / 5.0 mil fingertip
Sizes: S, M, L, XL
Colour: as requested
Finish: Textured fingertips / beaded cuff
Quality: AQL 1.5 or better, subject to the agreed product specification
Packaging: 100 gloves per box; 10 boxes per carton (1,000 gloves/carton), unless otherwise agreed
Compliance: Products supplied according to applicable medical device and quality requirements specified in the purchase agreement.
Regulatory & Testing Standards:
• Regulatory Clearance: Must have FDA 510(k) clearance as a Class I medical device (under 21 CFR §880.6250) for patient examination use.
• Primary Material Standard: Must strictly conform to ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application).
• Acceptable Quality Level (AQL): Standard AQL of 1.5 or lower for freedom from holes (meaning fewer than 1.5% of gloves in a batch fail the water leak test).
• Biocompatibility: Must pass ISO 10993 testing for skin irritation and dermal sensitization to protect both healthcare workers and patients.
Physical & Mechanical Properties:
Medical gloves require higher tensile strength than standard industrial options to prevent tearing during intense procedures:
• Tensile Strength: Minimum 14 MPa both before and after accelerated aging.
• Ultimate Elongation: Minimum 500% before aging, and minimum 400% after aging (ensures the glove stretches significantly before breaking).
• Physical Weight: Typically ranges from 3.5g to 5.0g per glove depending on the size and exact thickness.
Dimensional Benchmarks:
• Length: A minimum of 220 mm to 230 mm is required by standard, though standard commercial medical gloves are typically 240 mm (~9.5 inches) with a beaded cuff to prevent liquid roll-back.
• Thickness: Medical exam gloves strike a balance between barrier protection and tactile sensitivity:
• Palm: Minimum 0.05 mm (Typically 3.0 to 4.0 mil / 0.08 mm to 0.10 mm).
• Fingertips: Minimum 0.05 mm (Typically 3.5 to 4.5 mil / 0.09 mm to 0.12 mm).
Specialty Medical Classifications:
Depending on the specific hospital department, regular medical exam gloves may not be sufficient:
Medical Use Case Required Specification / Testing Key Characteristics
General Exam / Triage ASTM D6319, AQL 1.5 Standard thickness (3–4 mil); tactile sensitivity for palpation.
Oncology / Chemotherapy ASTM D6978 (Assessment of Resistance to Permeation by Chemotherapy Drugs) Thicker formulation, specially tested against cytotoxic drugs; distinct labeling on the box specifying breakthrough times.
Emergency / High-Risk Fentanyl Resistant (Tested under ASTM D6978) Often extended-cuff (12 inches) with protection against opioid permeation for up to 240 minutes.
Surgery Sterile-packaged, ASTM D3577 (for surgical gloves), AQL 1.0 Hand-specific pairs (left/right) rather than ambidextrous; tighter defect tolerances.
Material & Construction:
• Base Material: 100% synthetic nitrile butadiene rubber (NBR); contains no natural rubber latex proteins.
• Powder Status: Powder-free (treated via online chlorination, halogenation, or polymer coating to ease donning without cornstarch residue).
• Sterility: Non-sterile (standard examination or general-purpose).
• Design: Ambidextrous with a beaded/rolled cuff to prevent liquid roll-back and aid donning.
• Surface: Finger-textured or palm-textured for wet, dry, or oily grip.
• Colors: Commonly blue, black, white, purple, or pink
Dimensions & Thickness:
• Length: Typically 240 mm (9 inches) to 245 mm (9.5 inches) for standard cuffs, with extended-cuff variants available for high-risk settings.
• Thickness (Single Wall):
• Cuff: ~0.05 mm to 0.08 mm (approx. 2.0 to 3.5 mil)
• Palm: ~0.08 mm to 0.12 mm (approx. 3.0 to 4.5 mil)
• Finger: ~0.09 mm to 0.14 mm (approx. 3.5 to 5.5 mil)
• Sizes Available: Extra Small (XS), Small (S), Medium (M), Large (L), and Extra Large (XL).
Performance & Quality Standards:
• ASTM Standard: Tested and compliant with ASTM D6319 (Standard Specification for Nitrile Examination Gloves).
• Acceptable Quality Level (AQL): Typically ≤ 1.5 for medical/examination grade to ensure a low pinhole defect rate.
• Regulatory Compliance:
• FDA 510(k) cleared for medical examination use (where applicable).
• FDA Title 21 CFR compliant for indirect food contact/food service use.
• Shelf Life: Generally 3 to 5 years when stored in a cool, dry place away from direct sunlight.
