Bergamot Icon

TRUSTED PRODUCTS

Bergamot's core value of “Where requirements meet Perfection” leads us to serve our customers to the highest level of product safety & compliance.

Bergamot is a pioneer in introducing new technologies, and new materials to develop products for our end users.

Latex Powdered Examination Gloves

LATEX

EXAMINATION GLOVES
  • Biocompatibility tested
  • Chlorinated & polymer coated
  • Absorbable USP grade powder
  • Medical grade AQL 1.5
  • High grade latex compound
Nitrile Powder Free Gloves

NITRILE

EXAMINATION GLOVES
  • Biocompatibility tested
  • Medical grade AQL 1.5
  • Alternative for Type 1 allergies
  • Acrylonitrile-butadiene
  • Soft comfort with excellent grip
Vinyl Powder Free Gloves

VINYL

EXAMINATION GLOVES
  • 100% Latex free
  • 100% Protein free
  • Multipurpose usage
  • Extra comfort & odourless
  • Durable with tactile sensitivity
3 Ply Lint Free Facemask

MASK

LINT FREE FACE MASK
  • Single use only
  • Hypoallergenic
  • Non-woven fabric
  • Comfortable lining
  • Biocompatibility tested

global standards

In line with our direction of providing consistently high quality solutions – we emphasize on stringent quality control procedures in all our processes and strictly follow the global quality standards. Here are some of the standards that our products adhere to.

Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC, which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021.The regulation was published on 5 May 2017 and came into force on 25 May 2017. Originally approved medical devices will have a transition time of three years (until 26 May 2021) to meet new requirements.

Regulation (EU) 2016/425 of 9 March 2016 on personal protective equipment (the PPE regulation) covers the design, manufacture and marketing of personal protective equipment. It defines legal obligations to ensure that PPE on the EU internal market provides the highest level of protection against risks. The CE marking affixed to PPE provides evidence of compliance of the product with the applicable EU legislation.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Find out more.