# K050071: Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons Glove

- Pathway: 510(k) (Traditional)
- Applicant: H.B.M. USA Co.,Inc.
- Decided: May 11, 2005 after 119 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.
18 later devices descend from it; 1 cites it directly.
0 of 19 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) POWDERED LATEX SURGEON'S GLOVES by CEPHAS MEDICAL: named in the summary without a submission number
- (no number) Maxter Sterile Powder Free Surgical Gloves: named in the summary without a submission number

## Most influential descendants
- K063757: Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves (2007), 17 descendants of its own
- K130301: Latex Surgeon's Gloves (Powdered and Powder Free) (2013), 14 descendants of its own
- K151114: Medismart ( Latex Surgeon¿s Gloves powdered ) and  Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein (2015), 12 descendants of its own
- K172942: Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein (2018), 11 descendants of its own
- K192328: JR.MEDIK Latex Surgeon’s Gloves Powder Free (2020), 8 descendants of its own

## Indications for use
MEDISPO powdered surgeon's gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning,.and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. MEDISPO-PF powder-free surgeon's gloves are sterile disposable devices made of natural rubber 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.

Source page: https://510kreport.com/device/K050071
Methodology: https://510kreport.com/methodology