A Technical Data Sheet (TDS) is one of the most important documents a glove buyer receives from a supplier. It contains specifications, test results, certifications, and material information that determines whether a glove meets your requirements. This guide explains how to read each section of a glove TDS, what red flags to watch for, and how to verify claims against independent standards.

A Technical Data Sheet (TDS) is the primary document that communicates a glove product's specifications, performance characteristics, and compliance status. Unlike a Certificate of Conformity (CoC) which certifies that a specific batch meets requirements, a TDS describes the product design and typical performance. For procurement teams, the ability to read and verify a TDS is essential for qualifying suppliers, comparing products, and ensuring regulatory compliance. This guide breaks down each section of a typical glove TDS.

1. What Is a TDS and How Does It Differ from a CoC?

A TDS tells you what the glove is designed to do. A CoC tells you that a specific batch actually meets those design requirements. Both are necessary for thorough supplier qualification.

2. Section-by-Section TDS Breakdown

2.1 Product Identification

This section includes the product name, SKU, brand, and intended use. Verify that:

• The product name matches your procurement specification
• The intended use statement aligns with your application (medical examination, food handling, industrial, etc.)
• The SKU is current and not obsolete

2.2 Material Composition

The TDS should state the primary polymer and any additives:

2.3 Physical Properties

This is the most critical section for performance verification. Compare against the relevant standard:

2.4 Dimensions and Sizing

Verify that the sizing chart matches your user population. Key dimensions include:

• Palm width: Measured at the metacarpals; determines fit
• Length: Minimum length from cuff to fingertip (typically >= 240 mm for exam gloves)
• Cuff thickness: Important for durability during donning
• Finger thickness: Affects tactile sensitivity and puncture resistance

2.5 Quality Level (AQL)

The TDS should state the Acceptable Quality Level for pinholes:

• AQL 1.5: Standard for medical examination gloves (ASTM D6319, EN 455-1)
• AQL 0.65: Premium grade; lower defect rate
• AQL 2.5: Industrial grade; higher defect tolerance

Verify that the stated AQL matches your procurement requirements and the intended use.

2.6 Certifications and Standards Compliance

This section lists the standards and regulations the product is designed to meet. Verify each claim:

2.7 Shelf Life and Storage Conditions

Verify:

• Shelf life: Typical range 3-5 years for nitrile; 3 years for latex
• Storage temperature: Usually 10-30 degrees C
• Relative humidity: Typically below 65%
• Light protection: Away from direct sunlight and UV

3. Red Flags in a Glove TDS

4. How to Verify TDS Claims

1. Cross-check against standards: Compare each test value against the relevant ASTM, EN, or ISO requirement
2. Request independent test reports: Do not rely solely on supplier-generated TDS values; ask for third-party ISO 17025 lab reports
3. Verify certifications: Check FDA 510(k) numbers in the FDA database; verify CE certificates with the Notified Body
4. Request samples for internal testing: Water leak test, visual inspection, and fit evaluation on your own staff
5. Audit the manufacturing facility: ISO 13485 certification and on-site quality systems
6. Check lot traceability: Ensure the supplier can link any CoC back to the TDS and manufacturing batch

5. TDS vs Real-World Performance

A TDS describes the product under ideal test conditions. Real-world performance depends on:

• Storage conditions: Heat and humidity can degrade gloves before use
• Donning technique: Rough handling can cause micro-tears not detected by AQL testing
• Chemical exposure: The TDS does not test against all possible chemicals; verify specific chemical compatibility for industrial use
• Fit: A glove that meets all specs but fits poorly will fail in practice due to tearing or compromised dexterity

Data sources: ASTM D6319-19; EN 455-1 to EN 455-4; EN ISO 21420:2020; ISO 13485; ISO 17025; FDA 21 CFR 820; EU MDR 2017/745; ISO 10993 series. Information current as of September 2026.

FAQ

Q: What is the difference between a TDS and a CoC?

A: A Technical Data Sheet (TDS) describes the product design, materials, specifications, and typical performance for a product family or SKU. A Certificate of Conformity (CoC) certifies that a specific production batch meets the stated requirements. The TDS tells you what the glove is designed to do; the CoC tells you that a specific batch actually meets those requirements.

Q: What physical properties should I verify on a nitrile glove TDS?

A: For nitrile examination gloves, verify tensile strength >= 14 MPa (before and after aging), elongation >= 500% before aging and >= 400% after aging (per ASTM D6319), and AQL 1.5 for pinholes. If the glove claims EN 455 compliance, verify force at break >= 6.0 N for rubber examination gloves.

Q: How can I verify FDA 510(k) claims on a TDS?

A: Search the FDA 510(k) Premarket Notification database using the 510(k) number provided on the TDS. Verify that the device name and manufacturer match the TDS. The FDA database is publicly accessible at accessdata.fda.gov.

Q: What are red flags in a glove TDS?

A: Red flags include: missing test values, "typical values" without ranges, standards listed without supporting test data, outdated standard editions, no ISO 17025 lab accreditation, inconsistent units, and vague material descriptions like "synthetic rubber" without specifying the polymer type.

Q: Should I rely solely on the TDS for supplier qualification?

A: No. A TDS is a starting point, not proof of compliance. Always request independent third-party test reports from ISO 17025 accredited laboratories, verify certifications through official databases, request samples for internal evaluation, and conduct facility audits for critical suppliers.