BAM Surgical Gown, Standard, Reinforced, Ultra Reinforced

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Bam Standard Surgical Gown, Bam Reinforced Surgical Gown, Bam Ultra Reinforced Surgical Gown

510(k) Number

K093835 ↗

FDA Product Code

FYA

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Surgical Face Masks Plus Anti-Fog Shield

  Class II

  FDA 510(k) K933748 Active Cleared 17 Jun 1994

• Disposable Surgical Mask (Modified)

  Class II

  FDA 510(k) K931580 Active Cleared 2 May 1994

• Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns

  Class II

  FDA 510(k) K160337 Active Cleared 7 Jul 2017

• What are the key differences between the Standard, Reinforced, and Ultra Reinforced surgical gowns from Bam Corp.?

  The three variants—Standard, Reinforced, and Ultra Reinforced—are designed to offer varying levels of barrier protection for different surgical needs. While all are intended to shield against microbial contamination, body fluids, and particulate matter, the Reinforced and Ultra Reinforced models provide enhanced durability and protection in high-risk procedures where additional protection is required. The exact specifications for reinforcement levels are not detailed in the submission, but the distinction is made to accommodate procedural demands.

• Are these surgical gowns reusable, or are they intended for single-use only? How should they be stored to maintain sterility?

  These gowns are explicitly labeled as sterile, single-use items. To preserve sterility, they must be stored according to the manufacturer’s guidelines, which likely include keeping them in their original packaging, away from direct sunlight, moisture, or contamination, and within the recommended temperature and humidity ranges (though specific storage conditions are not detailed in the submission). Reuse is not supported or indicated for these gowns.

• What regulatory pathway was followed for FDA clearance of these surgical gowns, and how does that affect their use?

  The gowns were cleared via the FDA 510(k) pathway (K093835) under an abbreviated review process, with a determination of substantial equivalence (SESE) to predicate devices. This means they meet the same performance standards as existing, cleared gowns and comply with FDA’s requirements for surgical attire (product code FYA). Clinicians can rely on this clearance for use in controlled surgical environments, though no additional regulatory markings beyond the 510(k) designation are mentioned.

• Can these gowns be used in MRI environments, or are there any special considerations for their use?

  The regulatory submission does not mention MRI safety for these gowns, meaning there is no explicit indication they are MRI-compatible or tested for use in magnetic resonance imaging environments. If used near MRI equipment, clinicians should verify compatibility with the specific scanner manufacturer’s guidelines to avoid interference or safety risks. Standard surgical gown protocols should otherwise apply.

• How do I determine which size or model of these gowns is appropriate for a specific surgical procedure?

  While the submission does not provide detailed sizing charts, the three models—Standard, Reinforced, and Ultra Reinforced—are differentiated by barrier protection levels, not size. Sizing for surgical gowns typically follows standard industry measurements (e.g., chest, waist, length), which are likely available in the manufacturer’s product documentation or catalog. The choice between models should be based on procedural risks (e.g., high-fluid exposure or complex surgeries), while size selection should align with the user’s body measurements to ensure proper fit and coverage.