# K983998: Powder Free Latex Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Sri Anusham Rubber Industries Pvt., Ltd.
- Decided: Jan 21, 1999 after 73 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 Gloves (Powder Free), Type 1, manufactured primarily from Natural Rubber Latex, meeting ASTM D 3578-95: named in the summary without a submission number

## Indications for use
Fawder Free Latex Examination Glove is a device intended for medical use , warn by the Examiner on his hands 7/ fingers to prevent contamination between Patient and Examiner.

Source page: https://510kreport.com/device/K983998
Methodology: https://510kreport.com/methodology