# K964474: Ultrafree Sterile Latex Powder-Free Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Allegiance Healthcare Corp.
- Decided: Mar 11, 1997 after 124 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 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 its predicate without a number.
- (no number) Triflex Sterile Latex Powder-Free Surgical Gloves: named in the summary without a submission number

## Most influential descendants
- K120934: Protexis Latex Basic Sterile Latex Powder-Free Surgical Glove with Protein Content Label Claim of 50 UG/DM or Less (2012), 5 descendants of its own
- K121897: Protexis Latex Basic Sterile Powder-Free Surgical Gloves (2012), 4 descendants of its own
- K140988: Powder Free Sterile Latex Surgical Glove, Yellow Color (Brand Name: Titanfine) (2014), 3 descendants of its own
- K171550: Sterile Latex Surgical Gloves, Powder Free (2018), 2 descendants of its own
- K211953: Disposable Sterilized Latex Surgical Gloves (2022), 1 descendant of its own

## Indications for use
Ultrafree Sterile Latex Powder-Free Surgical Gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K964474
Methodology: https://510kreport.com/methodology