# K981767: Qtexx Powderfree Latex Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Latexx Partners Bhd.
- Decided: Jun 11, 1998 after 23 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Class 1 patient examination glove 80LYY: named in the summary without a submission number

## Most influential descendants
- K110250: MPXX Powder Free Natural Rubber Examination Gloves (2011), 3 descendants of its own
- K210253: Best Glove-Latex Powder Free Examination Glove (2021), 1 descendant of its own
- K221374: Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) (2022), 0 descendants of its own
- K121844: Powder Free Natural Rubber Latex Examination Gloves (2013), 0 descendants of its own

## Indications for use
OTEXX Powderfree Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

Source page: https://510kreport.com/device/K981767
Methodology: https://510kreport.com/methodology