Cleared Traditional

K192290 - 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192290 · Xuchang Zhengde Environstar Medical Products Co., Ltd. · General Hospital
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Apr 2020
Decision
251d
Days
Class 2
Risk

K192290 is an FDA 510(k) clearance for the 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Xuchang Zhengde Environstar Medical Products Co., Ltd. (Xuchang, CN). The FDA issued a Cleared decision on April 30, 2020 after a review of 251 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Xuchang Zhengde Environstar Medical Products Co., Ltd. devices

Submission Details

510(k) Number K192290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2019
Decision Date April 30, 2020
Days to Decision 251 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 128d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 292
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