# K964142: Medline Disposable Surgical Drapes and Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Feb 25, 1997 after 132 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
29 later devices descend from it; 5 cite it directly.
0 of 30 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 no predicate by number.

## Most influential descendants
- K012186: Master & Frank Surgical Gowns (Sterile) (2001), 23 descendants of its own
- K100971: Atek Surgical Gowns (2010), 21 descendants of its own
- K120192: Disposable Surgical Gowns (2012), 20 descendants of its own
- K172987: Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) (2018), 19 descendants of its own
- K211422: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown (2021), 11 descendants of its own

## Recalls of this device
- Apr 11, 2018 · Class II · Z-2010-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1963-2018: Product sterility may be compromised due to unsealed packaging.
- Jun 1, 2017 · Class II · Z-3079-2017: The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.

Source page: https://510kreport.com/device/K964142
Methodology: https://510kreport.com/methodology