# K133956: Nitrile Powder Free Examination Glove with Colloidal Oatmeal Usp Skin Protectant Drug - White / Dawn Blue / Lemon Green

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega Sdn Bhd
- Decided: May 28, 2014 after 156 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White (Lavender Scent) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner The Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue (Lavender Scent) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner The Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Lemon Green (Lavender Scent) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner

Source page: https://510kreport.com/device/K133956
Methodology: https://510kreport.com/methodology