# K993857: The Original Perry, Style 42 White Latex Powdered Surgical Gloves with Protein Content Labeling Claim (60 Micrograms or

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Perry
- Decided: Jan 31, 2000 after 77 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- 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 no predicate by number.

## Indications for use
The Original Perry Style 42 Surgeon's gloves intended use is to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K993857
Methodology: https://510kreport.com/methodology