Certificates and Standards :

ASTM

ASTM D3578 Standard Specification for Rubber Examination gloves for Medical Application

Length: Min 220mm (XS-S), MIN 230mm (M-XL)
Thickness Single wall finger and Palm: Min 0.08mm

Elongation (Before/After aging): Before 650%/ After 500%
Tensile Strength (Before/After aging): Before 18Mpa/ After 14Mpa Waterlight test: AQL 2.5

ISO11193

ISO 11193 is worldwide standard for single-use medical examination gloves

Latex Examination ISO 11193 Specification

Length: Min 220 mm (XS-S), MIN 230 mm (M-XL)

Thickness Single wall finger and Palm:
smooth Min 0.08 mm /Textured Min 0.11 mm
Elongation (Before/After aging): Before 650%/ After 500%
Force (Before/After aging): Before 7N/ After 6N
Waterlight test: AQL 2.5

TISI 1056-2556

TISI 1056-2556 is Thailand standard for single-use medical examination gloves.

Latex Examination TISI 1056-2556 Specification

Length: Min 220 mm (XS-S), MIN 230 mm (M-XL)
Thickness Single wall finger and Palm:
smooth Min 0.08 mm /Textured Min 0.11 mm
Elongation (Before/After aging): Before 650%/ After 500%
Force (Before/After aging): Before 7N/ After 6N
Waterlight test: AQL 2.5

EN455

EN455 is European specification requirement for Latex and Nitrile medical gloves.

Length: Median 240mm
Thickness: Follow ASTM
Elongation (Before/After aging): Before 500%/ After 400%
Force (Before/After aging): Before 6N/ After 6N
Waterlight test: AQL 1.5

ASTM

ASTM D6319 Standard Specification for Nitrile Examination gloves for Medical Application

Length: Min 220mm (XS-S), MIN 230mm (M-XL)
Thickness Single wall finger and Palm: Min 0.05mm

Elongation (Before/After aging): Before 500%/ After 400%
Tensile Strength (Before/After aging): Before 14Mpa/ After 14Mpa Waterlight test: AQL 2.5

ISO11193

ISO 11193 is worldwide standard for single-use medical examination gloves

Nitrile Examination ISO 11193 Specification

Length: Min 220 mm (XS-S), MIN 230 mm (M-XL)
Thickness Single wall finger and Palm:
smooth Min 0.08 mm /Textured Min 0.11 mm
Elongation (Before/After aging): Before 500%/ After 400%
Force (Before/After aging): Before 7N/ After 7N
Waterlight test: AQL 2.5

TISI 1056-2556

TISI 1056-2556 is Thailand standard for single-use medical examination gloves.

Nitrile Examination TISI 1056-2556 Specification

International Organization for Standardization ISO 9001 / ISO 13485

International Organization for Standardization 9001 and 13485 – the Quality Management System for Medical Devices developed in accordance with the requirements of ISO 9001; ISO 13485 is an international standard containing requirements for medical devices intended to guarantee the highest quality of products and their compliance with the law and customer expectations.

EU type-examination certificate

EU-type examination certificate – EU-type examination is a procedure whereby a notified body ascertains and attests that the product, including its technical documentation and relevant life-cycle processes, as well as a representative sample of the envisaged product, complies with the relevant provisions.

CE certificate for medical gloves

CE certificate for medical gloves – the CE mark indicates that the product can be legally sold in any EU country. EU regulations require the use of the CE mark, so gloves must be marked with this symbol. The CE mark may qualify gloves as a medical device, personal protective equipment or both.

FDA 510(k) registration

US Food and Drug Administration 510(K) – this is a notification issued prior to placing the item on the market. It contains detailed technical information for medical devices to confirm that the relevant product is “substantially equivalent” to a product already sold in the US market.

Thai FDA