Nitrile Gloves & EU Standards
Varun Mittal
Sustainable ?? Food Packaging | Compostable Paper products | Exports | Euroco Pack
Industrial and Medical grade gloves are two of the biggest categories when it comes to gloves. But what do these labels really mean?
Medical Grade Gloves / Surgical Gloves:
Disposable gloves used during medical examinations in the medical field must have FDA approval. Their strength can withhold against and protect an individual against blood borne pathogens. Latex’s harsh proteins are known to cause allergies and skin irritation after prolonged use. The FDA has also forbid the use of powdered gloves in the medical industry due to their higher risk factors during procedures.
The FDA tests the gloves thoroughly for the following:
- Puncture resistance
- Tear resistance
- Tension
- Chemical resistance
Standard EN455 Part 1 - 4 Medical Gloves for Single Use:
1. EN455-1 Requirements ,and testing for freedom from holes.
2. EN455-2 Requirements and testing for physical properties - Dimensions and strength.
3. EN455-3 Requirements and testing for Endotoxins, Latex Proteins,Chemical Residues, Powder.
4. EN455-4 Requirements and testing for shelf life determination.
Other important standards
- Standard EN 1186 Food Contact - Glove manufacturer must go through to ensure that a plastic article is suitable for food contact ( Aqueous,Alcoholic,Acidic,Fatty). the following symbol can be applied to the glove and/or packaging.
Class 1 FDA: - Medical gloves are disposable and include examination gloves, surgical gloves, and medical gloves for handling chemotherapy agents (chemotherapy gloves). These gloves are regulated by the FDA as Class I reserved medical device.
Thickness of the gloves 2.5mil and 3.5mil. 2.5mil is standard size customer are buying, but sometime customer have specific requirment for 3.5mil. Please also note that if gloves price is cheaper, please verify EU standard and thickness carfully.
Normally all the manufacturing unit having ISO9001, CE, GMP.
Industrial Gloves:
Nitrile gloves made to withstand industrial purposes are designed to be 3 to 5 times more puncture and chemical resistant than latex. They best serve the following jobs…
- Automotive
- Home Use
- Janitorial and Sanitation
- Beauty Services
- Food Services
- Plumbing
- Painting
- Chemical and Safety
They have mainly three european standard EN374, EN 388 and EN420.
Sustainable ?? Food Packaging | Compostable Paper products | Exports | Euroco Pack
4 年[email protected]
Thanks
Founder
4 年I saw many food handler are using sergical handgloves in their daily operation which is not recommended in food handling. People don't know the difference between these two categories. Even Medical shop's are selling 3Rs. gloves pair in 20Rs. in Hinjewadi area.