# K993133: Cashmere Non-Sterile Powdered Nitrile Examination Gloves Blue and Green

- Pathway: 510(k) (Traditional)
- Applicant: Seal Polymer Industries Bhd.
- Decided: Nov 17, 1999 after 58 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.
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 Nitrile Patient Examination Glove 80 LZA, powdered with absorbable dusting powder: named in the summary without a submission number

## Indications for use
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients’ body, fluids, waste or environment.

Source page: https://510kreport.com/device/K993133
Methodology: https://510kreport.com/methodology