# K992171: Coated Sterile Latex Powder-Free Surgical Gloves with Protein Content Labeling Claim (50 Micrograms or Less)

- Pathway: 510(k) (Traditional)
- Applicant: Allegiance Healthcare Corp.
- Decided: Sep 14, 1999 after 78 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 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) Ultrafree Sterile Latex Powder-Free Surgical Gloves: named in the summary without a submission number

## Most influential descendants
- K101811: Protegrity SMT Latex Surgicalgloves (2010), 3 descendants of its own
- K111015: Sterile Latex Powder Free Surgical Gloves with Hydrogel Coating (2011), 2 descendants of its own
- K151778: Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (2016), 1 descendant of its own
- K160875: Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (2016), 0 descendants of its own
- K070647: Triflex Select (2007), 0 descendants of its own

## Indications for use
These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as 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/K992171
Methodology: https://510kreport.com/methodology