Cleared Traditional

K230707 - Skypro

K230707 is an FDA 510(k) clearance for Skypro, manufactured by Skypro Medical Supplies Company. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K230707 · Skypro Medical Supplies Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K230707

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.

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 163
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