# K012104: Snow Lotus Powder-Free Latex Surgeon's Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Reagent Latex Products Co., Ltd.
- Decided: Aug 21, 2001 after 47 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.
No later device cites it as a predicate yet.
0 of 1 device 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 (Powder Free): named in the summary without a submission number

## Indications for use
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. (21CFR 878.4460)

Source page: https://510kreport.com/device/K012104
Methodology: https://510kreport.com/methodology