Cleared Traditional

K093169 - SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)

K093169 is an FDA 510(k) clearance for SURGIPLUS STANDARD SURGICAL GOWN (STERI..., manufactured by A Plus International, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K093169 · A Plus International, Inc. · General Hospital
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Nov 2009
Decision
36d
Days
Class 2
Risk

K093169 is an FDA 510(k) clearance for the SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICA.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by A Plus International, Inc. (Chino, US). The FDA issued a Cleared decision on November 12, 2009 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all A Plus International, Inc. devices

FDA 510(k) Submission Details - K093169

510(k) Number K093169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2009
Decision Date November 12, 2009
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FYA Gown, Surgical

All 242
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K093169.
EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL
K101593 · Exact Medical Manufacturing, Inc. · Sep 2010
KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100
K093115 · Kimberly-Clark Corp. · Mar 2010
LAC-MAC INNERBLOC LR SURGICAL GOWNS
K092344 · Lac Mac, Ltd. · Dec 2009
MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400
K091357 · Kimberly-Clark Corp. · Aug 2009
SRI LEVEL II SURGICAL GOWN
K090383 · Sri Surgical · May 2009
PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501
K091097 · Promedical Products Co., Ltd. · May 2009

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.