# K133953: Latex Powder Free Examination Gloves with Colloidal Oatmeal Usp Skin Protectant Drug with Protein Labeling Claim of 50 M

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega Sdn Bhd
- Decided: May 28, 2014 after 156 days
- Product code: LYY (Latex 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove - Lemon Green (Lavender Scent) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove - Lemon Green (Lavender Scent) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K133953
Methodology: https://510kreport.com/methodology