# K101822: Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Sgmp Co., Ltd.
- Decided: Nov 19, 2010 after 142 days
- Product code: LZC (Medical Glove, Specialty)
- 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: 1 generation back to K082957 (2009). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082957: Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer Coated, Tested with Chemotherapy Drugs, Siam Sempermed Corp., Ltd. (2009) Summary page 3.

## Most influential descendants
- K111248: Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) (2011), 4 descendants of its own
- K211810: Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) (2022), 1 descendant of its own
- K193666: Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff (2020), 1 descendant of its own
- K243796: GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] (2025), 0 descendants of its own
- K232064: Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) (2023), 0 descendants of its own

## Indications for use
The Non-sterile Powder Free Blue Nitrile Examination Gloves Tested for use with Chemotherapy Drugs, is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes The following chemical have been tested with these gloves. Test Chemotherapy Drug — Average Breakthrough Detection Time (Minutes) Carmustine (BCNU) — 0.49 minutes* Cisplatin — >240 minutes Cyclophosphamide — >240 minutes Doxorubicin Hydrochloride — >240 minutes Etoposide (Toposar) — >240 minutes Flurouracil — >240 minutes Paclitaxel (Taxol) — >240 minutes Thiotepa — 2.61 minutes* Vincristine Sulfate — >240 minutes Dacarbazine (DTIC) — >240 minutes Methotrexate — >240 minutes *Please note that Carmustine (BCNU) and Thiotepa have extremely low permeation times of 0.49 and 2.61 minute only.

Source page: https://510kreport.com/device/K101822
Methodology: https://510kreport.com/methodology