Nitrile Exam Gloves for Hospitals
Most of the world was unprepared for a pandemic like COVID-19. The contagion caused many supply chain issues including a shortage of medical supplies like gloves, N95 masks and, isolation gowns. With the need for these supplies continuing, some scammers are attempting to profit by manufacturing fake or low quality gloves with fake packaging. It’s important for value analysis and purchasing departments to avoid buying them. Not only are they a financial loss, but they could also put hospital staff and patients at risk. Here’s how to evaluate the quality of nitrile exam gloves for hospitals.
What You Need to Know About FDA 510K Approval
The FDA requires some medical device manufacturers to register with them when they plan to advertise a medical device. Under section 510K, these companies must notify the FDA of their marketing agenda at least 90 days before they intend to implement it.
This alert is called Premarket Notification. The FDA requires this step to determine if the product is equal to a device that’s already in one of the government agency’s three classification sections. That way, the FDA can identify medical devices properly.
For medical examination gloves the FDA approves the glove with a product code to confirm the approval for the intended use. LZA is the product code issued to Nitrile Examination gloves to confirm that the gloves are intended for medical purposes and are worn on the examiner’s hands or fingers to prevent contamination between patient and examiner. Other important product approval codes are OPJ which is for Medical Gloves with Chemotherapy Labeling Claims, and QDO which is an approval for Fentanyl and other Opioid Protection Gloves. The FDA includes in their 510K approval letter all of the associated testing that was submitted for review by the manufacturer to achieve the respective product code.
Look for ASTM D6319 TestingGlove manufacturers are required to provide testing that meets ASTM standards. ASTM International is a nonprofit global standards organization that develops and distributes technical standards for a variety of products including medical equipment. Companies that produce their products according to ASTM D6319 standards are able to offer their customers the assurance that they are selling Examination grade gloves that are manufactured for medical use.
When gloves meet the ASTM D6319 standard, they are powder free, thicker than disposable gloves designed for other purposes and include a higher tensile strength level.
The ASTM testing standards for chemo tested nitrile exam gloves consists of checking the material’s strength and flexibility. The organization’s tests are designed to make sure that an examination glove is unlikely to tear or fail and provides the proper amount of stretch.
When a powder free examination glove box confirms that its contents have been ASTM tested, then the gloves have undergone an accelerated aging process that involves heat. This test is designed to assess how well the gloves will work toward the end of their shelf life, giving you peace of mind that they will continue to provide protection until they are expired.
Check for ASTM Chemotherapy Drug Testing Standards
Since chemotherapy agents are extremely toxic, it’s important for healthcare employees to handle them wearing examination gloves that have been tested for saturation using the ASTM’s more vigorous D6978 standard instead of the guidelines used for other chemicals.
The chemotherapy drug testing standards require companies to test the gloves for up to four hours. The permeation test measures the time that it takes certain chemicals to make their way through the material of the latex free glove. For a glove to be considered safe for chemotherapy drugs, the tests must take place at particular temperatures too.
Understand the Ins and Outs of Factory Standards
ASTM standards include AQL testing, or Acceptable Quality Level. For example ASTM D6319-10 includes an AQL of 2.5%. Before buying gloves from any company, make sure that you know how they test their products. Check the label for Acceptance Quality Limit, or AQL, testing. The definition of AQL testing is a “quality level that is the worst tolerable.” It refers to the highest number of faulty products allowed in a batch before that batch is discarded. For instance, if a label states that the AQL is 1.5%, then this means that the glove batch cannot contain more than 1.5% faulty items in the order. Of course ASTM standards are set at an AQL of 2.5%, but some factories have an AQL of 1.5% which means they have stricter quality control levels.
Since the development of COVID-19 has caused a shortage of the raw materials needed to make nitrile examination gloves, defrauders have appeared on the scene to take advantage of hospitals and steal their money. When you buy quality tested nitrile exam gloves, your facility will be stocked with powder free gloves that are also latex free. To avoid becoming victim to a scam, watch for suspicious activity like uncommon payment requirements, sudden price increases and unexpected bulk supplies.
Read the Information that is Printed on the Medical Glove Box
The label printed on the glove box is important. It should include a list of tests that the manufacturer performed to confirm the quality of the gloves and their safety. When you purchase examination gloves, make sure that the boxes are labeled with information like:
- Patient examination glove or surgeon’s glove
- Tested for permeation resistance to chemotherapy drugs according to ASTM D6978-05
- What chemotherapy drugs the gloves have been tested against
- Chemical resistance data
The label should also show you the number of chemotherapy drugs that the gloves were tested against and the amount of drugs used during testing.
Label information is important because it allows you to confirm that you have exam gloves that are manufactured to provide the proper protection for your healthcare staff.
Keep in mind that packaging is simple for manufacturers to produce, making it the easiest thing to fake. If you run into a scammer, the box may falsely state that tests and standards have taken place when they haven’t. To keep your hospital staff protected, request third-party testing documents from your supplier. That way, you can confirm that you’re purchasing quality nitrile exam gloves.
Keeping Hospitals Stocked with Chemo Tested Nitrile Exam Gloves
Currently, the cost for raw materials to manufacture medical gloves has shot up quickly due to a lack of supplies and more demand because of COVID-19. Despite these challenges, SPH Medical is working tirelessly to provide consistent glove supplies to its hospital clients.
Sources:
1. https://webstore.ansi.org/sdo/astm
2. https://hourglass-intl.com/glove-testing-demystified-tensile-strength-and-ultimate-elongation/
3. https://www.pppmag.com/article/1623/January_2015/Are_Gloves_and_Gowns_Safe_for_Handling_Chemotherapy/#:~:text=ASTM%20standard%20D6978%20is%20specific,care%20workers%20handle%20chemotherapy%20drugs.
4. https://www.fbi.gov/news/pressrel/press-releases/fbi-warns-health-care-professionals-of-increased-potential-for-fraudulent-sales-of-covid-19-related-medical-equipment
5. FDA Product classification codes for Medical Gloves https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&Submission_Type_ID=&DeviceName=&ProductCode=&DeviceClass=1&ThirdParty=&Panel=&RegulationNumber=880.6250&Implant_Flag=&Life_Sustain_Support_Flag=&PAGENUM=500&sortcolumn=DeviceNameDESC