# K994131: Ambiderm Powderfree Latex Examination Gloves with a Protein Claim of 50 Micrograms or Less Per Gram (Black Colored)

- Pathway: 510(k) (Traditional)
- Applicant: Medtaxx Partners
- Decided: Feb 7, 2000 after 62 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 I patient examination glove: named in the summary without a submission number

## Indications for use
AMBIDERM Powder Free Latex Examination Glove (Black Colored), polymer coated, with a protein labeling claim 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/K994131
Methodology: https://510kreport.com/methodology