# K014278: Latex Surgeons Glove (Powdered)

- Pathway: 510(k) (Traditional)
- Applicant: Brightway Gloves Pvt., Ltd.
- Decided: May 14, 2002 after 138 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Class I Surgeon’s Glove (Powdered): named in the summary without a submission number

## Most influential descendants
- K023139: Romed Latex Surgical Gloves, Powdered, Sterile (2003), 0 descendants of its own

## Indications for use
Surgeon’s glove (powdered) is a sterile medical device made of natural latex intended to be worn by operating room personnel to protect a surgical wound from contamination and is powdered with absorbable dusting powder USP corn starch as the donning lubricant.

Source page: https://510kreport.com/device/K014278
Methodology: https://510kreport.com/methodology