There are two main differences between a glove used in a clean environment and a glove for exam / medical application: cleanliness and cost. Though the actual manufacturing process used for both gloves is similar, the post-manufacturing processes distinguish them and dictate the difference in cost.
Gloves for Exam / Medical Applications
Exam gloves serve as a barrier protection for pathogens, protecting both patient and healthcare worker. Exam gloves are tested for strength, pinholes, and thickness, and require a 501K certification from the FDA allowing them to be sold as a Class 1 medical device. Cleanroom gloves carry much higher classification requirements.
Gloves for examination are required to have an AQL (Accepted Quality Limit) level of 1.5 vs. 4.0 for industrial-rated gloves.
Paper boxes are commonly used to package exam gloves for convenient, low cost dispensing. The downside to paper packaging is that it is a source of particulate contamination. They are not recommended for use, therefore, even in less critical cleanroom applications.
Gloves for Contamination Control / Cleanroom Applications
Cleanroom gloves protect a product or process from the person handling or performing them. Contamination within a cleanroom process can occur from small, unseen particles or residue negatively effecting the cleanroom process.
Like exam gloves, clean room gloves are tested for strength and integrity. However, these gloves also undergo particle, extraction (ionic), and NVR (non-volatile residue) testing to ensure very high levels of cleanliness.
To obtain the various level classifications required, they must be chlorinated, washed – often multiple times – with deionized, filtered water, then rinsed, dried, and packaged in bags rather than boxes. Processing of cleanroom gloves is usually done in a cleanroom, and the packaging bags are produced in a cleanroom.
These additional processing requirements account for the higher costs charged for these gloves, which are available in Class 10, Class 100, and Class 1,000 medical device classifications. Gloves for critical applications should be selected according to the specific application and environment requirements in which they will be used.
Choosing the Right Glove
Ultimately, choosing the right glove for a facility depends on the size of particle and type of contamination capable of causing a failure in your process or product. Quality clean room glove manufacturers provide detailed particle test results for evaluating which gloves are best for your environment and facility.
Identifying and using the correct cleanroom glove may require a series of trial evaluations to find the glove best-suited to producing better yields by reducing failure rates. Knowing the cause and cost of failure verses the cost of improvement will help you increase successful production.Exam Gloves >> Cleanroom Gloves >>