Cleared Traditional

BODILY FLUID DISPOSAL KIT

K961217 · Transidyne General Corp. · General Hospital
Jul 1996
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K961217 is an FDA 510(k) clearance for the BODILY FLUID DISPOSAL KIT, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Transidyne General Corp. (Spartanburg, US). The FDA issued a Cleared decision on July 25, 1996, 119 days after receiving the submission on March 28, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K961217 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1996
Decision Date July 25, 1996
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FXX — Mask, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

Similar Devices — FXX Mask, Surgical

All 605
Surgical Face Mask (Ear mount)
K252534 · Zhejiang Hangkang Medical Equipment Co., Ltd. · Mar 2026
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
K253398 · Efofex, Inc. · Feb 2026
Disposable Surgical Face Mask (3P00B, C2900)
K252830 · Beatles Medical Supplies (Xiantao) Co., Ltd. · Jan 2026
Disposable Medical Face Mask
K252650 · Makrite Industries, Inc. · Jan 2026
KP Protective Face Mask
K243342 · Kp Trading Co., Ltd. · Dec 2025
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
K252941 · O&M Halyard, Inc. · Dec 2025