# K060030: The Double Glove

- Pathway: 510(k) (Traditional)
- Applicant: Biobarrier, Inc.
- Decided: Jun 27, 2006 after 174 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 K033564 (2004). 1 ancestor in all.
4 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)
- K033564: Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional Labeling Claim of E.P. Less Than 50 UG/DM2, Kanam Latex Industries Pvt., Ltd. (2004) Summary page 1.

## Most influential descendants
- K071465: Biogel Orthopaedic Surgical Glove with Non-Pryogenic Statement (2007), 2 descendants of its own
- K071565: Biogel Indicator Underglove with Non-Pyrogenic Statement (2007), 1 descendant of its own
- K112089: Biogel Orthopor Brown Surgical Glove (2011), 0 descendants of its own
- K101163: Biogel Orthopro Indicator Underglove (2010), 0 descendants of its own

## Indications for use
The 'powder-free, polymer coated, sterile surgeon's glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Source page: https://510kreport.com/device/K060030
Methodology: https://510kreport.com/methodology