Clean your Health and Life

CLEARDIY testing's are mandatory sections in FDA 510k submission for examination and surgical gloves, most of the cases these tests are conducted on a third-party lab. Besides the biocompatibility testing, the below in-house tests are also required in 510k notification and test results must comply with approved standards like ASTM and ISO.

Certification

OUR GLOVE PRODUCTS FULLY COMPLY WITH THE STANDARDS OF ALL COUNTRIES IN THE WORLD

USA FDA 510(k)

CLEARDIY testing's are mandatory sections in FDA 510k submission for examination and surgical gloves, most of the cases these tests are conducted on a third-party lab. Besides the biocompatibility testing, the below in-house tests are also required in 510k notification and test results must comply with approved standards like ASTM and ISO.

CE MEDICAL DEVICE FOR EURO

In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements for medical devices, which will soon change under the new Medical Devices Regulation (MDR 2017/745).

MEDICAL DEVICE FOR USA

ASTM D6319 covers certain requirements for nitrile rubber gloves used in medical applications. Standard specifies various test methods including sterility testing, physical dimensions testing, physical requirements testing, powder residue, and powder limit testing. This page covers physical requirement tests to determine the tensile strength and the ultimate elongation of medical glove samples.

ISO 13485 Medical Device

ISO 13485 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 requirements and regulatory requirements applicable to medical devices and related services.

Disposable Gloves

OUR GLOVE PRODUCTS FULLY COMPLY WITH THE STANDARDS OF ALL COUNTRIES IN THE WORLD

Nitrile Disposable Gloves Medical/Food Grade
  • FDA 510k, CE MDR, ISO 13485 Medical Device certified
  • No latax protection to cause allergy
  • Excellent softness and wearing fitness
  • Undifferentated shelf life as normal gloves
  • Tested for use with over 60 chemicals
  • Approved for use with chemotherapy drugs
Nitrile Disposable Gloves industrial Grade
  • 6 mil, Black Powder Free Nitrilel
  • Component materials comply with all federal regulations for food contact
  • Industrial / Food Service Grade
  • Undifferentated shelf life as normal gloves
  • Rolled Cuff/Textured Grip
  • Black color hides soiling
$75
Vinyl Disposable Gloves Medical/Food Grade
  • FDA 510k, CE MDR, ISO 13485 Medical Device certified
  • Increased protectich, resisting acid, alkali and oil/li>
  • PU coating with no protein, limiting allergy risk
  • Increased cost parformance
  • Longer wearing time than nitrile gloves
  • Easier donning than standard vinyl gloves
$15
MEDICAL DISPOSABLE FACE MASK
  • upport USA FDA 510k , ASTM F2100 level 1 & 2
  • Blocks most pathogens such as bacteria and viruses
  • Soft to skin and comfortable
  • Surface moisture resistance
  • 50 masks per pack
$95

Contact Us

 

Wide Angle International LLC.

116 S Ave 60 Los Angeles CA USA 90042

info@cleardiy.com