Cleared Traditional

K960048 - EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS

K960048 is an FDA 510(k) clearance for EZ-PERSONAL PROTECTION KIT WITH SPILL C..., 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 190-day FDA review.

K960048 · Safetec of America, Inc. · General Hospital
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Jul 1996
Decision
190d
Days
Class 2
Risk

K960048 is an FDA 510(k) clearance for the EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS. 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 July 12, 1996 after a review of 190 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 Safetec of America, Inc. devices

FDA 510(k) Submission Details - K960048

510(k) Number K960048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1996
Decision Date July 12, 1996
Days to Decision 190 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 129d · This submission: 190d
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 495
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K960048.
N95 FILTERING FACEPIECE
K962443 · Survivair, Inc. · Jan 1997
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K962286 · Berkley Medical Resources, Inc. · Oct 1996
BODILY FLUID DISPOSAL KIT
K961217 · Transidyne General Corp. · Jul 1996
STS SHIELD WITH MASK
K961402 · Innovative Outsourcing Solutions · Jul 1996
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K955382 · 3M Company · May 1996
FLUID RESISTANT MASK
K955556 · American Threshold Healthcare · Apr 1996