Our policy is not simply to follow ISO 9002 guidelines, but to strive for excellence in every way possible.
Quality Control
Direct QC on the line is a regular practice to ensure that every glove is classified according to its quality standard. The parameters control systems for the raw materials used and operational process are set up to conform to the relevant or specific sections of the USA FDA's Good Manufacturing Practices (GMP), ISO 9001:2000, ASTM & EN455 Standards.
Quality Assurance Program
To ensure the perfection of DR.BOO® gloves, we apply an In-House Quality Assurance Program for every lot of gloves before shipping.
- Watertight inspection : AQL Level
- Physical properties : tensile strength, elongation and force at break
- Dimension measurement
- Protein content level
- Powder level
- Bio-burden
We are ISO 9001 : 2000 certified and accredited international standard for ASTM D3578, ASTM D3577, an EN 455. We are also listed in the FDA Medical Device Listings, and are complied wit the US-FDA Pre-Market 510 (k) Notification. |