# K121844: Powder Free Natural Rubber Latex Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Worldmed Manufacturing Sdn. Bhd.
- Decided: Sep 6, 2013 after 438 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
Longest line of descent: 2 generations back to K981767 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110250: MPXX Powder Free Natural Rubber Examination Gloves, Total Gloves Sdn Bhd (2011) Summary page 1.
- K101799: Powder Free Latex Examination Gloves Blue (Colored), Non-Sterile, with Protein Labeling Claim of 50UG Per DM2 of Glove, Wear Safe (Malaysia) Sdn. Bhd. (2010) Summary page 1.

## Indications for use
The Powder Free Natural Rubber Latex Examination Gloves Is a single use disposable device Intended for medical purposes that Is worn on the hands of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient;

Source page: https://510kreport.com/device/K121844
Methodology: https://510kreport.com/methodology