Cleared Traditional

K133075 - Plus Surgical Gowns (EO Sterilized), PMGB-XXX

K133075 is an FDA 510(k) clearance for Plus Surgical Gowns (EO Sterilized), manufactured by Foshan Nanhai Plus Medical Co, Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 632-day FDA review.

K133075 · Foshan Nanhai Plus Medical Co, Ltd. · General Hospital
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Jun 2015
Decision
632d
Days
Class 2
Risk

K133075 is an FDA 510(k) clearance for the Plus Surgical Gowns (EO Sterilized), PMGB-XXX. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Foshan Nanhai Plus Medical Co, Ltd. (Dover, US). The FDA issued a Cleared decision on June 24, 2015 after a review of 632 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. 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 Foshan Nanhai Plus Medical Co, Ltd. devices

FDA 510(k) Submission Details - K133075

510(k) Number K133075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date June 24, 2015
Days to Decision 632 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
503d slower than avg
Panel avg: 129d · This submission: 632d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 240
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K133075.
ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500
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Blockade Surgical Gown
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Aero Chrome* Breathable Performance Surgical Gown
K153255 · Halyard Health, Inc. · Apr 2016
SmartGownTM surgical gown
K150151 · Cardinal Health 200, Inc. · May 2015
SURGICAL GOWN
K141467 · Xuchang Zhengde Environstar Medical Products Co.,L · Mar 2015
SURGICAL GOWN
K141606 · Cobes Industries Co., Ltd. · Nov 2014