Cleared Abbreviated

BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN (K093835) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K093835 · Bam Corp., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
416d
Days
Class 2
Risk

K093835 is an FDA 510(k) clearance for the BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCE.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Bam Corp., Ltd. (Committee Rd.,Shatin, N.T., HK). The FDA issued a Cleared decision on February 4, 2011 after a review of 416 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Bam Corp., Ltd. devices

Submission Details

510(k) Number K093835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2009
Decision Date February 04, 2011
Days to Decision 416 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
287d slower than avg
Panel avg: 129d · This submission: 416d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FYA Gown, Surgical

All 294
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K093835.
Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
K252575 · New York Embroidery Studio (NYES) · Jun 2026
BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
K260725 · Hindernis DE Mexico, S.A.P.I. DE C.V. · May 2026
Cardinal Health™ Poly Reinforced Surgical Gown
K253243 · Cardinal Health 200, LLC · Apr 2026
Non-sterile Level 3 Surgical Gown (4025)
K253003 · Hubei Xinxin Non-Woven Co., Ltd. · Apr 2026
Copioumed AAMI 3 Surgical Gown
K251860 · Copioumed International, Inc. · Feb 2026
Henan Yadu Level 4 Surgical Gowns (Reinforced)
K252301 · Yadu Medical (Henan) Co., Ltd. · Feb 2026