# K982872: TG Medical Powder-Free Latex Examination Glove Protein Labeling Claim (50 Micrograms or Less)

- Pathway: 510(k) (Traditional)
- Applicant: Tg Medical Sdn. Bhd.
- Decided: Oct 15, 1998 after 62 days
- Product code: LYY (Latex Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Apr 10, 2006 · Not classified · Z-0909-06: FDA's laboratory analysis found holes in the gloves that exceeded the allowable limit. Gloves with holes compromise the integrity of the latex barrier and have the potential to allow hazardous substan

## Indications for use
Latex examination powderfree gloves are worn on the hands of health care and similar personel to prevent contamination between health care personnel and the patient.

Source page: https://510kreport.com/device/K982872
Methodology: https://510kreport.com/methodology