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Requirements and standard numbers for different industries

For the US and European markets, disposable nitrile gloves and reusable protection gloves have specific compliance requirements and corresponding standard numbers for different industries (such as medical, industrial, food processing, etc.).

US market

Disposable nitrile gloves

Medical industry

Compliance requirements: Gloves must be non-toxic and harmless, have good chemical resistance and puncture resistance, and should meet medical-grade hygiene standards.

Standard number: ASTM D6319 (Standard Specification for Nitrile Rubber Medical Examination Gloves), ASTM D6977 (Standard Guide for Nitrile Rubber Medical Gloves), etc.

Industrial industry

Compliance requirements: Gloves should have good abrasion resistance, anti-static and tear resistance to adapt to high-intensity operations in industrial environments.

Standard number: ASTM D3578 (Standard Specification for Nitrile Rubber Examination Gloves), etc., and may also involve ANSI/ISEA 105 (performance standards for gloves, covering cutting, puncture resistance, chemical protection, etc.).

Food handling industry

Compliance requirements: Glove materials must be non-toxic, odorless, and powder-free to avoid contaminating food, and should have good sealing and anti-slip properties.

Standard number: Although there is no specific standard number for disposable nitrile gloves in the food handling industry in the United States, they should generally meet the relevant requirements of the FDA (U.S. Food and Drug Administration), such as FDA CFR177.2600.

Reusable protection gloves

Medical industry

The compliance requirements are the same as those of disposable nitrile gloves.

Standard number: Also refer to ASTM D6319, ASTM D6977, etc.

Industrial industry

The compliance requirements are similar to those of disposable nitrile gloves, but may focus more on abrasion resistance and tear resistance.

Standard number: ANSI/ISEA 105, etc.

Food handling industry

The compliance requirements are the same as those of disposable nitrile gloves.

Standard number: It should also meet the relevant requirements of the FDA, such as FDA CFR177.2600.

European Market

Disposable Nitrile Gloves

Medical Industry

Compliance Requirements: Gloves must be non-toxic, harmless, have good chemical resistance and puncture resistance, and meet medical-grade hygiene standards.

Standard Number: EN 455 (Requirements and Tests for Gloves for Medical Devices).

Industrial Industry

Compliance Requirements: Gloves should have good abrasion resistance, anti-static and tear resistance, and may also involve chemical and microbial protection.

Standard Number: EN 374 (Personal Protective Equipment for Chemical and Microbial Contamination), EN 388 (Personal Protective Equipment for Mechanical Risks), etc.

Food Processing Industry

Compliance Requirements: Glove materials must be non-toxic, odorless, and powder-free to avoid contaminating food, and should have good sealing and anti-slip properties.

Standard Number: Although there is no specific standard number for disposable nitrile gloves for the food processing industry in Europe, they should generally meet the relevant EU regulations on food contact materials, such as EC 1935/2004, etc.

Reusable Protection Gloves

Medical Industry

Compliance requirements are the same as those for disposable nitrile gloves.

Standard number: Also refer to EN 455.

Industrial industry

Compliance requirements are similar to those of disposable nitrile gloves, but may focus more on abrasion resistance and tear resistance.

Standard number: EN 374, EN 388, etc.

Food handling industry

Compliance requirements are the same as those of disposable nitrile gloves.

Standard number: It should also meet the relevant EU regulations on food contact materials.


In addition, for protective gloves exported to the EU, it is also necessary to meet the relevant requirements of CE certification, including filling out application forms, submitting for testing, writing technical documents, and submitting certification applications to NB agencies. The CE certification directive divides protective gloves into three categories according to the risk level that the product intends to protect, and different categories of gloves have different testing and certification requirements.

In summary, there are differences in the compliance requirements and standard numbers for disposable nitrile gloves and reusable protection gloves in the US and European markets. When selecting and using gloves, the appropriate type and specifications should be selected according to the specific market, industry, and working environment, and ensure that they meet the corresponding standards and regulatory requirements.

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