# K121335: G-Derm Powder-Free Synthetic Surgical Glove

- Pathway: 510(k) (Traditional)
- Applicant: Hutchinson Sante S.N.C.
- Decided: Sep 13, 2012 after 133 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: 2 generations back to K902831 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020918: Elastyfree Synthetic Powder-Free Surgical Glove, Eci Medical Technologies, Inc. (2002) Summary page 1.
- K994081: Safeskin Tactylon PF Powder-Free Surgeon's Gloves, Safeskin Corp. (2000) Summary page 1.
- K955419: Powder Free Tactylon Surgeons Glove, Tactyl Technologies, Inc. (1996) Summary page 1.

## Indications for use
The G-Derm TM Surgical Glove is a disposable sterile powder-free medical device made of styrene-ethylene/butylene-styrene (SEBS) and styrene-ethylene/propylene-styrene-ethylene/propylene (SEPSEP) synthetic copolymers that is intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K121335
Methodology: https://510kreport.com/methodology