Sterile vs Non Sterile Gloves: Which One to Wear?

The important things we should know about sterile vs non sterile gloves are their qualifications and designated purposes in certain duties.

Sterile gloves definition provided by certifications of the U.S. Food and Drug Administration (FDA) for their techniques. They are formulated to perform surgical medical procedures. Meanwhile, non sterile gloves are for medical examinations and other non-surgical services.

Regarding the Acceptable quality level (AQL) of pinholes, sterile gloves have to meet a stricter requirement of below 1.5% per tested set, while non sterile gloves’ AQL is below 2.5 %.

FDA Medical Device Guide About Sterile Gloves

According to FDA standards, the sterile gloves of surgeons must be made from synthetic rubber. As surgical procedures require medical personnel to protect the patient’s wounds from any possible contaminations and surgical site infections, their device, including gloves, must be sterile.

Please note that this requirement does not include the dusting powder or lubricating agent applied to the sterile gloves.

Regarding the classifications of FDA standards for sterilization techniques of surgical gloves, it is the Class 1 device. The sterile gloves meet the design requirements of the FDA Quality System Regulation for notifying 90 days prior to the marketing process.

When producing sterile gloves, manufacturers must have their products undergo a sterilization process to be tested whether they meet the FDA’s Standard Assurance Level (SAL).

In detail, the sterility test of the sterile technique is based on the requirement of a SAL of 10^-6. And it requires a SAL of 10^− 3 for higher risk procedures of intact skin contact in surgery.

Here’re the sterilization standards recognized by the FDA:

A sample set of sterile gloves must meet the acceptable quality level (AQL) to have pinholes of 1.0 – 1.5 %. Also, surgical gloves must meet the performance criteria of biocompatibility in medical procedures and resistance to tears and leaks.

FDA Medical Device Guide About Non Sterile Gloves

Non sterile meaning the glove does not conform to the sterility assurance level (SAL). For non surgical procedures like examining in dental procedures, a non sterile glove suffices. Common single-used devices for medical care are poly gloves (latex free for medical personnel or patients with latex allergy), vinyl gloves (powder and latex free), and nitrile pairs (powder and natural rubber latex free).

There are some standards for this type of gloves, including:

Regarding the acceptable quality level of non sterile gloves in a sample set, its AQL must be from 1.5 – 2.5. That means the number of gloves with pinholes in the submitted gloves for testing must be below 2.5%.

Hand Hygiene and other Requirements in Using Sterile Gloves vs Non Sterile Gloves

Conclusion

There must be no haphazard behaviors in using medical gloves, so everyone should be aware of certain information. For instance, we must know the difference between sterile vs non-sterile gloves and follow the regulation for their utilization.

Also, to purchase the right type of device for our work, make sure to check out the qualifications and standards that the gloves must meet. That way, we can protect our health and other’s safety while handling daily duties.

Do not hesitate to reach out to us in case you have any confusion about this guide.

Alexander M. Thompson

Hi, I am Alexander, forty-seven years old this year. I have been in the construction industry for twenty-five years and have provided a wide range of services. When it comes to expert guidance on site safety gear, you can put your trust in me.