# K151997: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Mar 31, 2016 after 255 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K222225: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) (2022), 1 descendant of its own
- K243818: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (2025), 0 descendants of its own
- K162095: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) (2016), 0 descendants of its own

## Indications for use
The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU) is nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) is as below: Carmustine (3.3 mg/ml) 10.2 minutes Cisplatin (1.0 mg/ml) >240 minutes Cyclophosphamide (20 mg/ml) >240 minutes Dacarbazine (10.0 mglml) >240 minutes Doxorubicin Hydrochloride (2.0 mg/ml) >240 minutes Etoposide (20.0 mg/ml) >240 minutes Fluorouracil (50.0 mg/ml) >240 minutes Methotrexate (25 mg/ml) >240 minutes Mitomycin C (0.5 mg/ml) >240 minutes Paclitaxel (6.0 mg/ml) >240 minutes Thiotepa (10.0 mg/ml) 30.2 minutes Vincristine Sulfate (1.0 mg/ml) >240 minutes Please note that Carmustine and Thiotepa have extremely low permeation times of 10.2 minutes and 30.2 minutes.

Source page: https://510kreport.com/device/K151997
Methodology: https://510kreport.com/methodology