Cleared Traditional

K960073 - EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP

K960073 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 FYA cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K960073 · Safetec of America, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
189d
Days
Class 2
Risk

K960073 is an FDA 510(k) clearance for the EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP. Classified as Gown, Surgical (product code FYA), 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 189 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 - K960073

510(k) Number K960073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1996
Decision Date July 12, 1996
Days to Decision 189 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
60d slower than avg
Panel avg: 129d · This submission: 189d
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 205
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K960073.
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL
K961239 · Depuy, Inc. · Sep 1996
ROBISON & SMITH SURGICAL PACKS
K955586 · Robison & Smith, Inc. · Aug 1996
OREX SURGEON'S VEST
K961083 · Thantex Specialties, Inc. · Aug 1996
STRYKER STERI-SHIELD SURGICAL APPAREL
K944393 · Stryker Corp. · Aug 1995
COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS
K945371 · Standard Textile Co., Inc. · Apr 1995
PERVAL SURGICAL GOWN (MARKETING NAME)
K950504 · Standard Textile Co., Inc. · Apr 1995