# K022873: Powder-Free Radiation Attenuating Neoprene Surgical Glove (Black)

- Pathway: 510(k) (Traditional)
- Applicant: International Biomedical, Inc.
- Decided: Mar 21, 2003 after 204 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
Longest line of descent: 1 generation back to K891968 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891968: Esp Radiation Reduction Examination Gloves, Boston Scientific Corp (1989) Summary page 1.
- K990710: Barrierplus Synthetic Powder-Free Surgical Gloves, Barriermed Glove Co. (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K821720: Physiological Display System, Model 1000, Novametrix Medical Systems, Inc. (1982). Our reading of the summary gave K821720, FDA’s number for Physiological Display System, Model 1000 (Novametrix Medical Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Radiation Attenuating Surgical Glove”. Kept off the family tree.

## Indications for use
A powder-free surgeon’s glove is a device made of synthetic latex that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. The radiation attenuating surgical glove is intended to be used during medical procedures where hands are necessarily exposed to radiation in order to offer some degree of protection to the hand from radiation. This includes surgical procedures that require the use of fluoroscopy or radiography.

Source page: https://510kreport.com/device/K022873
Methodology: https://510kreport.com/methodology