Cleared Traditional

K952962 - EZ-PERSONAL PROTECTION KIT

K952962 is an FDA 510(k) clearance for EZ-PERSONAL PROTECTION KIT, manufactured by Safetec of America, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K952962 · Safetec of America, Inc. · General Hospital
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Sep 1995
Decision
93d
Days
Class 2
Risk

K952962 is an FDA 510(k) clearance for the EZ-PERSONAL PROTECTION KIT. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Safetec of America, Inc. (Buffalo, US). The FDA issued a Cleared decision on September 27, 1995 after a review of 93 days - within the typical 510(k) review window.

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 Safetec of America, Inc. devices

FDA 510(k) Submission Details - K952962

510(k) Number K952962 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received June 26, 1995
Decision Date September 27, 1995
Days to Decision 93 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 129d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, 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 - FXX Mask, Surgical

All 496
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K952962.
GLOBAL HEALTHCARE FACE MASK
K953754 · Global Healthcare, Inc. · Jan 1996
BODY FLUID BARRIER KIT
K952961 · Lhb Industries, Inc. · Jan 1996
BLOODBORNE PATHOGEN KIT
K953102 · Certified Safety Mfg., Inc. · Dec 1995
PENTAX FACE MASK
K933683 · Pentax Precision Instrument Corp. · Jun 1995
BUSSE ISOLATION AND PROCEDURAL MASKS
K940720 · Busse Hospital Disposables, Inc. · Nov 1994
3M SURGICAL MASK WITH FACE SHEILD
K940707 · 3M Company · May 1994