Device Information
The Powder-Free Nitrile Examination Glove is ambidextrous and comes in various sizes, from Extra Small to Extra Large. It is non-sterile and designed for single use.
Indications
The gloves are disposable and intended to prevent contamination between the patient and examiner. They are specifically tested for use with chemotherapy drugs, Fentanyl Citrate, and other select drugs.
Intended Use
These Powder Free Nitrile Examination Glove 2.8 Blue Color Non-Sterile gloves are for healthcare professionals handling chemotherapy drugs and Fentanyl Citrate. They can be used in various medical environments, including hospitals and clinics. Both prescription and over-the-counter availability are supported.
Availability
The gloves are available over-the-counter (OTC).
Warning
Do not use with Carmustine (1.7 minutes permeation time) or Thiotepa (0 minutes permeation time).
Study Results
- Clinical Testing: No clinical test were done per 510k documentation.
- Nonclinical and Safety Testing: The gloves were tested for chemotherapy drug permeation, achieving more than 240 minutes for most drugs except Carmustine and Thiotepa. Tests followed ASTM D6319-19 and ASTM D6978-05 standards for physical properties, chemotherapy drug permeation, and skin sensitization. No skin irritation or sensitization reactions were observed during testing.
Regulatory Information
- Regulation Number: 21 CFR 880.6250
- Regulatory Class: Class I, reserved
- Product Code: LZA, LZC, QDO, OPJ
- The device complies with ASTM D6319-19 and D6978-05 for drug permeation testing and medical glove standards.
Manufacturer Information
- Name: Anhui Intco Medical Products Co., Ltd.
- Address: No. 6, Haitang South Road, Suixi Wuhu Modern Industrial Park, Suixi County, Huaibei City, Anhui Province, China
- Contact Person: Max Li
Predicate Device Information
- Predicate Device Name: Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- 510(k) Number: K223713
- The predicate device is similar but differs in color and size options. Both devices meet the same safety and performance standards.
Implications
The Powder Free Nitrile Examination Glove 2.8 Blue Color Non-Sterile gloves provide a reliable option for medical professionals handling hazardous drugs. They are designed to protect both the user and the patient from contamination and drug permeation.
References
- Powder Free Nitrile Examination Glove 2.8 Blue Color. 510(k) Number: K233598. FDA Summary https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K233598
- http://www.intcomedical.com
- https://redica.com/document-store/sites/siteprofile/100253281/anhui-intco-medical-products-co-ltd-huaibei-china
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