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510(k) Data Aggregation
K Number
K222733Device Name
Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)
Manufacturer
Date Cleared
2022-12-11
(93 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Inner Mongolia Boming Medical Supplies Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|----------------------------|------------------------|----------------------------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 23.7 Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | 240 Minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | 240 Minutes |
| Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | 240 Minutes |
| Etoposide | 20.0 mg/ml(20,000 ppm) | 240 Minutes |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | 240 Minutes |
| Methotrexate | 25 mg/ml(25,000 ppm) | 240 Minutes |
| Mitomycin C | 0.5 mg/ml(500 ppm) | 240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | 240 Minutes |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 45.7 Minutes |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | 240 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.7 Minutes Thio-Tepa 10.0 mg/ml 45.7 Minutes
Caution: Testing showed an average breakthrough time of 45.7 minutes with Thio-Tepa
WARNING: Do not use with Carmustine
Device Description
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered non-sterile and in five sizes: extra-small, small, medium, large, and extra-large.
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K Number
K212467Device Name
Disposable Nitrile Examination Glove
Manufacturer
Date Cleared
2021-11-04
(90 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Inner Mongolia Boming Medical Supplies Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Device Description
The subject device is powder free nitrile patient examination gloves. The subject device is blue color. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.
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