# K093835: Bam Standard Surgical Gown, Bam Reinforced Surgical Gown, Bam Ultra Reinforced Surgical Gown

- Pathway: 510(k) (Abbreviated)
- Applicant: Bam Corp., Ltd.
- Decided: Feb 4, 2011 after 416 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- 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) Kimberly Clark Ultra Surgical Gown: named in the summary without a submission number
- (no number) Kimberly Clark Ultra Reinforced Surgical Gown: named in the summary without a submission number

## Indications for use
BAM STANDARD, REINFORCED AND ULTRA REINFORCED SURGICAL GOWNS are sterile, single use, blue SMS Surgical Gowns intended to protect surgical patients and operating room personnel from the transfer of micro-organisms, body fluids and particulate material. The BAM STANDARD and REINFORCED SURGICAL GOWNS meet Level 3 of AAMI Liquid Barrier Classifications and the BAM ULTRA REINFORCED GOWNS meet Level 4 of the AAMI Liquid Barrier Classifications in their critical zones. The base material of the gowns is the same for the three categories. The sizing is the same except the BAM ULTRA REINFORCED GOWNS are longer. The only other difference is the chest and sleeve reinforcement panels added. BAM Reinforced blue SMS Surgical Gowns have a one layer SMS fabric added to the chest and sleeves. BAM Ultra Reinforced Blue SMS Surgical Gowns have a PET + PE film reinforcement added to the chest and sleeves. These gowns have been EtO sterilized. BAM STANDARD, REINFORCED AND ULTRA REINFORCED SURGICAL GOWNS are also sold as bulk non-sterile, single use items, to repackager/ relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

Source page: https://510kreport.com/device/K093835
Methodology: https://510kreport.com/methodology