Cleared Abbreviated

K093835 - BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN

K093835 is an FDA 510(k) clearance for BAM STANDARD SURGICAL GOWN, manufactured by Bam Corp., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Abbreviated 510(k) pathway after a 416-day FDA review.

K093835 · Bam Corp., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K093835

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
287d slower than avg
Panel avg: 129d · This submission: 416d
Pathway characteristics
Standards-based clearance path.

FYA Device Classification - Class 2, Special Controls

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 270
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K093835.
3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE
K101468 · 3M Company Corp · Apr 2011
SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO
K102692 · Hangzhou Jincheng Medical Supplier Manufacture Co. · Mar 2011
FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
K102971 · Microtek Medical, Inc. · Feb 2011
NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS
K102652 · Gri Medical & Electronic Technology Co., Ltd. · Feb 2011
MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS
K103406 · Kimberly-Clark Corp. · Dec 2010
ATEK SURGICAL GOWNS
K100971 · Hangzhou Atek Medical & Textile Co., Ltd. · Sep 2010
K093835 · BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN
Download PDF FDA Summary Bam Corp., Ltd.