# K122000: HM Surgical Drapes HM Surgical Equipment Cover

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Holymed Products Co., Ltd.
- Decided: Dec 12, 2012 after 156 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
HM surgical drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. HM surgical drapes ame disposable, single use, sterile or nonsterile. Non-sterile HIM surgical drapes are to be sold to repackagerlrelabeler establishments for Eta sterilization according to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO sterilization validation to ISO 11135-1. Drapes am provided as below HM Surgical Equipment Covers are intended to be used to cover surgical equipment and provide a protective bordler for that equipment HM surgical equipment cavern are disposable, single use, sterile or nonsterile. Non-sterile HM surgical equipment covers are to be sold to repackager/relabeler establishments for EtO sterilization accrding to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO steriiztion validation to 180 11135-1. Drape are provided as below

Source page: https://510kreport.com/device/K122000
Methodology: https://510kreport.com/methodology