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510(k) Data Aggregation
K Number
K212532Device Name
Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)
Manufacturer
Date Cleared
2021-11-11
(92 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
CRDLight Optoelectronic Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Disposable Powder Free Nitrile Exam Glove (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Summarized in Table below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration (mg/mL) | Breakthrough time (minutes) |
|------------------------------|-----------------------|-----------------------------|
| Carmustine (BCNU) | 3.3 mg/mL | 6.2min |
| Cisplatin | 1.0 mg/mL | >240min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/mL | >240min |
| Dacarbazine (DTIC) | 10.0 mg/mL | >240min |
| Doxorubicin HCL (Adriamycin) | 2.0 mg/mL | >240min |
| Etoposide (Toposar) | 20.0 mg/mL | >240min |
| Fluorouracil (Adrucil) | 50.0 mg/mL | >240min |
| Paclitaxel (Taxol) | 6.0 mg/mL | >240min |
| ThioTEPA | 10.0 mg/mL | 8.4min |
| Methotrexate | 25.0 mg/mL | >240min |
| Vincristine sulfate | 1.0 mg/mL | >240min |
Do not use with Carmustine or ThioTEPA.
Device Description
The Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves. The gloves are offered in sizes small, medium, large, extra large packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).
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