# K993117: Safeskin Pfe-Xtra Powder-Free Latex Examination Gloves, Protein Content 50 MCG or Less, for Use with Chemotherapeutic AG

- Pathway: 510(k) (Traditional)
- Applicant: Safeskin Corp.
- Decided: Mar 2, 2000 after 164 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) Safeskin powder free examination glove: named in the summary without a submission number

## Indications for use
A medical examination glove intended to be worn on the hands of healthcare personnel and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.

Source page: https://510kreport.com/device/K993117
Methodology: https://510kreport.com/methodology