# K983489: Encore Mark IV Powder Free Polymer Coated Latex Surgical Glove with Protein Content Labeling Claim (50 Micrograms or LE)

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Perry
- Decided: Dec 14, 1998 after 70 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices 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.

## Most influential descendants
- K202765: ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs (2021), 1 descendant of its own
- K103714: Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemothera (2011), 1 descendant of its own
- K232444: Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs (2023), 0 descendants of its own
- K210724: ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs (2021), 0 descendants of its own

## Indications for use
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K983489
Methodology: https://510kreport.com/methodology