Cleared Traditional

Skypro, Surgical Gown 6021 (K230707) - FDA 510(k) Clearance

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

K230707 · Skypro Medical Supplies Company · General Hospital
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Oct 2023
Decision
212d
Days
Class 2
Risk

K230707 is an FDA 510(k) clearance for the Skypro, Surgical Gown 6021. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Skypro Medical Supplies Company (Hong Kong, CN). The FDA issued a Cleared decision on October 12, 2023 after a review of 212 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 Skypro Medical Supplies Company devices

Submission Details

510(k) Number K230707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2023
Decision Date October 12, 2023
Days to Decision 212 days
Submission Type Traditional
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
83d slower than avg
Panel avg: 129d · This submission: 212d
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 105
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K230707.
GCI Surgical Gown
K233571 · George Courey, Inc. · Aug 2024
Disposable Surgical Gown
K233068 · Nanning Tecbod Biological Technology Co., Ltd. · Mar 2024
Surgical Gown (40083)
K233183 · Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. · Feb 2024
Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
K230610 · Dongguan Shin YI Healthcare Products Factory · Aug 2023
Surgical Gown (S,M,L,XL,XXL,XXXL)
K231510 · Xiantao Zhibo Non-Woven Products Co., Ltd. · Aug 2023
Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
K230577 · Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi · Aug 2023