# K111248: Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Yty Industry (Manjung) Sdn Bhd
- Decided: Dec 1, 2011 after 212 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: 2 generations back to K082957 (2009). 2 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K101822: Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, Sgmp Co., Ltd. (2010) Summary page 3.

## Most influential descendants
- 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
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient an examiner. Chemotherapy Drug Permeation (breakthrough detection time) in minutes. The following chemicals have been tested with these gloves: Carboplatin, 10 mg/ml >240 minutes; Carmustine (BCNU, 3.3 mg/ml) 1.84 minutes for Original Blue and 1.82 minutes for Cobalt Blue; Cisplatin, 1.0 mg/ml >240 minutes; Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 minutes; Dacarbazine (DTIC), 10.0 mg/ml >240 minutes; Doxorubicin Hydrochloride, 2.0 mg/ml >240 minutes; Etoposide (Toposar), 20.0 mg/ml >240 minutes; Fluorouracil, 50.0 mg/ml >240 minutes; Ifosfamide, 50.0 mg/ml >240 minutes; Methotrexate, 25 mg/ml >240 minutes; Mitomycin C, 0.5 mg/ml >240 minutes; Mitoxantrone, 2 mg/ml >240 minutes; Paclitaxel (Taxol), 6.0 mg/ml >240 minutes; Thiotepa, 10.0 mg/ml 0.76 minutes for Original Blue and 0.9 minutes for Cobalt Blue; Vincristine Sulfate, 1.0 mg/ml >240 minutes. Please note that Carmustine (BCNU) and Thiotepa have extremely low permeation times for both glove colors. These two chemicals are not recommended for use with either color of the gloves.

Source page: https://510kreport.com/device/K111248
Methodology: https://510kreport.com/methodology