# K022548: Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Latexx Manufacturing Sdn.Bhd.
- Decided: Aug 15, 2002 after 14 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.
48 later devices descend from it; 2 cite it directly.
0 of 49 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 I patient examination glove bearing product code 80UA: named in the summary without a submission number
- (no number) Class 1 patient examination glove bearing product code 80LW: named in the summary without a submission number

## Most influential descendants
- K172930: mCare Powder-free Blue Nitrile Examination Gloves (2018), 46 descendants of its own
- K192333: Blue Nitrile Examination Gloves Powder Free (2020), 43 descendants of its own
- K202384: Palm Care Blue Nitrile Examination Gloves Powder Free (2020), 8 descendants of its own
- K203191: LYDUS Nitrile Examination Gloves, Powder Free (2021), 6 descendants of its own
- K211515: Nitrile Examination Gloves (2021), 2 descendants of its own

## Indications for use
Blue Colour Powder Free Nitrile Rubber Examination Gloves is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Source page: https://510kreport.com/device/K022548
Methodology: https://510kreport.com/methodology