# K101645: Non-Chlorinated, Polymer Coated Powder Free Natural Rubber Latex Examination Gloves and Protein Labeling Claim of

- Pathway: 510(k) (Traditional)
- Applicant: Latexx Manufacturing Sdn.Bhd.
- Decided: Aug 26, 2010 after 76 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. The FDA summary names its predicate without a number.
- (no number) Class 1 Patient Examination Glove: named in the summary without a submission number

## Indications for use
Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove and Protein Labeling Claim of 50 Micrograms or Les Protein is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Source page: https://510kreport.com/device/K101645
Methodology: https://510kreport.com/methodology