# K222733: Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)

- Pathway: 510(k) (Traditional)
- Applicant: Inner Mongolia Boming Medical Supplies Co., Ltd.
- Decided: Dec 11, 2022 after 93 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K042805 (2004). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201390: Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs), Medline Industires, Inc. (2020) Summary page 5.

## Indications for 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

Source page: https://510kreport.com/device/K222733
Methodology: https://510kreport.com/methodology