# K973615: Skingard TPF/Aosstex TPF/Sensifree/Essential TPF/Ameriglo TPF Latex Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Macro Rubber Industrial, Inc.
- Decided: May 20, 1998 after 239 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 Satin Plus Latex Examination Gloves: named in the summary without a submission number

## Indications for use
The latex examination gloves are used in both the Medical & Dental Communities, to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K973615
Methodology: https://510kreport.com/methodology