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System Certification , ISO 13485:2016 ,

Certification of compliance Disposable medical gloves

Post at 16/03/2021

After masks, antibacterial hand sanitizers, medical gloves and disposable gloves are the next product at risk of ‘burning’ goods due to the COVID-19 pandemic caused by the new corona virus (SARS-CoV- 2). Many people wear disposable medical gloves to avoid touching potentially contaminated surfaces in public.

As with other medical devices, gloves must be certified to be compliant with gloves before being marketed. Certification of single-use glove compliance, which is a must. Therefore, reputable manufacturers need to seek quality standard certification for disposable medical gloves.

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Legal grounds

TCVN 6343-1:2007 (ISO 11193-1:2002) Disposable medical gloves

>>> Download ISO 11193-1: 2002, Disposable medical examination gloves

What are disposable medical gloves?

Medical gloves (disposable gloves) are disposable gloves for medical use; procedure to help prevent cross-contamination between caregivers and patients.

The distinction of left and right hands plus softness of the product brings a sense of comfort and integrity for the user. In addition, there will be a sense of comfort with the function of reducing hand sweat, not causing discomfort.

  • Smooth surface feels natural, comfortable and easier to handle. At the same time, the wrists are contoured, making them easy to wear and avoid tearing.
  • Made from various polymers including latex, nitrile rubber, polyvinyl chloride and neoprene; they must not be mixed with flour, or mixed with cornstarch to lubricate gloves, making them easier to put on their hands.
  • Protein and chemical levels on gloves are lowest to limit skin allergies for the user.


Certification of compliance with disposable gloves

Scope of application
  • This International Standard specifies the specifications for sealed non-sterile sterile rubber gloves or gloves to be used in medical examination and diagnosis or treatment, to protect against disease transmission. between patient and user.
  • This International Standard also includes latex gloves for handling contaminated medical specimens and gloves with a smooth or rough surface on part or all of the glove.
  • This International Standard specifies the performance and safety of medical latex gloves. The safety and proper use of glove and disinfection procedures with subsequent handling, packaging and storage procedures are not covered by this International Standard.
Procedures for certifying the standard conformity of disposable gloves
Step 1: Register for a certificate

Step 2: The Vietnamese Quality Expert evaluates the factory condition; Sampling products for testing

Step 3: Issue product certificate of conformity with standards (valid for 03 years)

Step 4: Announcing product standard conformity


Deployment time

The implementation time for glove standard conformity certification depends on many factors such as internal implementation progress, factory condition assessment results, quality assurance conditions, and time to return results. product of the laboratory.

A typical timeframe is as follows:

  • Certification evaluation + Sample test: 15 to 30 days.
  • Announcing product standard conformity from 15 to 20 days.
Benefits apply
  • Reducing product costs by reducing costs of handling defective products;
  • The standard conformity certificate is a reliable and accepted proof of bidding;
  • Increasing competitive opportunities in the market;
  • Meet national statutory requirements;
  • Gain the trust of customers and consumers;
  • Satisfy the needs of consumers.
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