Cleared Traditional

Stryker Steri-Shield 8 Surgical Hoods and Togas

K241272 · Stryker Instruments · General Hospital
Oct 2024
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K241272 is an FDA 510(k) clearance for the Stryker Steri-Shield 8 Surgical Hoods and Togas, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on October 16, 2024, 163 days after receiving the submission on May 6, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K241272 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2024
Decision Date October 16, 2024
Days to Decision 163 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FYA — Gown, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

Similar Devices — FYA Gown, Surgical

All 290
Copioumed AAMI 3 Surgical Gown
K251860 · Copioumed International, Inc. · Feb 2026
Henan Yadu Level 4 Surgical Gowns (Reinforced)
K252301 · Yadu Medical (Henan) Co., Ltd. · Feb 2026
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
K250564 · Yadu Medical (Henan) Co., Ltd. · Dec 2025
ViVi? Toga Premium
K243522 · Thi Total Healthcare Innovation GmbH · May 2025
Dream Medi Sterile Surgical Gown (SurgicalGownUL)
K242937 · Dae Myung Chemical Co., Ltd. (Vietnam) · May 2025
Medline Level 4 Surgical Gown with Breathable Sleeves
K242844 · Medline Industries, LP · Feb 2025

More from Stryker Instruments

View all
RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer
K251971 · OLO · Sep 2025
PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
K250483 · GEI · Sep 2025
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
K250213 · GXI · May 2025
OptaBlate Radiofrequency (RF) Generator System
K250327 · GEI · Apr 2025
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K243930 · LFL · Mar 2025