Resources Subcategory: General

What type of testing is required for a medical glove to receive a 510(k) clearance?

A 510(k) is a premarket submission made to FDA to demonstrate that the medical glove to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed medical glove. Medical gloves must be biologically compatible with human skin. To assess this, the FDA requires two biological tests: Primary skin irritation (PSI), …

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What is the measurement of glove thickness and how does it affect glove applications?

The thickness of disposable gloves is measured in mils. A mil equals one-thousandth of an inch (0.001 inch). Disposable gloves can be as thick as 8 to 15 mils, but general purpose disposable gloves are typically 2 to 4 mils thick. For comparison, a plastic grocery bag is around 3 mils thick. Thinner gloves are …

What is the measurement of glove thickness and how does it affect glove applications? Read More »

Thinnest gloves offer least protection to the users. Is that true?

This is a common misconception by most glove users. Users should not judge the level of protection purely based on glove’s thickness. Instead, it is best verified against the various performance requirement testing that the gloves have underwent according to the relevant international glove standards. At Hartalega, with the modern advancement of glove technology, thin …

Thinnest gloves offer least protection to the users. Is that true? Read More »

Some dentists’ feedback with regards to nitrile glove usage is that it is slippery and cannot hold well to dental equipment. Is this a common setback as compared to latex gloves?

Generally, latex gloves exhibit better wet grip and hence feel less slippery. However, with the latest technology employed in glove production, nitrile gloves have significantly improved in wet grip. During the initial period of glove switching from latex to nitrile, users might need some time to get accustomed to the different characteristics and ‘feel’ of …

Some dentists’ feedback with regards to nitrile glove usage is that it is slippery and cannot hold well to dental equipment. Is this a common setback as compared to latex gloves? Read More »