Medical Gloves:

Testing and Certifications

The glove as a medical device is an essential barrier against cross-contamination between patient and operator. In accordance with Regulation (EU) 2017/745 (MDR) and EN 455 standards, we test the product’s impermeability, strength, and biocompatibility. We offer constant assistance in verifying technical and documentary requirements, ensuring you achieve full compliance in the shortest possible time.

Access all regulations
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HOW CERTIFICATION WORKS

Certification process: from sample to certificate

A clear 5-step process, estimated timelines, and required documents to achieve CE marking.

  • 1) Pre-assessment:
    Product and standards; category I/II/III and modules (B; C2/D). Testing plan, checklist, and timelines.
  • 2) Sample Submission:
    Representative samples + Bill of Materials (BOM), instructions, and forms. Fast-track intake.
  • 3) Testing/Verification:
    Tests according to current standards. Clear updates; targeted corrections if required.
  • 4) Reporting:
    Test and evaluation report; ready for the DoC and Technical File.
  • 5) Certification / Surveillance:
    EU Type-Examination Certificate (Module B) valid up to 5 years; annual C2 or D surveillance (Cat. III). Retain DoC and Technical File for 10 years.
Frequently Asked Questions
Frequently Asked Questions (FAQ)

For over 40 years, CIMAC has been testing and certifying safety footwear (PPE) in accordance with Regulation (EU) 2016/425 and current harmonised standards (e.g., EN ISO 20345/46/47).

We cover the entire range: safety shoes, firefighter boots, chainsaw-resistant footwear, foundry and welding boots, electrically insulating boots, motorcycling footwear, and chemical protection. Clear pathways, sample checklists, and technical support through to CE marking.

Validity of Certifications and Document Retention

Retain the EU Declaration of Conformity and technical documentation for 10 years from the date the PPE is placed on the market. The EU Type-Examination Certificate (Module B) has a maximum validity of 5 years from the date of issue, unless the reference harmonised standard is revised. Module C2 and Module D are subject to annual surveillance.

The EN 455 standard requires rigorous testing for the absence of holes (watertightness), physical properties such as tensile strength (before and after accelerated aging), and biological evaluation. We perform these analyses to ensure that the glove maintains its integrity during clinical use. We provide constant technical assistance to validate these performances in the shortest possible time.

A glove can be simultaneously certified as PPE (Regulation EU 2016/425) to protect the operator and as a Medical Device (Regulation EU 2017/745) to protect the patient.

We analyze the requirements of both regulations to coordinate a single, efficient testing process. Our support allows you to obtain dual compliance smoothly and in the shortest possible time.

To avoid adverse reactions in patients and operators, we test for latex protein content (if present) and the presence of potentially irritating powders or chemical residues.

We verify that the product complies with the biological safety limits set by harmonized standards. We assist you in reviewing test reports to ensure a safe product for the market in the shortest possible time.

Labeling must clearly state the batch number, expiration date, storage instructions, and intended use (e.g., examination or surgical glove).

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