Cleared Traditional

K821044 - PATIENT PREP KITS/TRAYS-STERILE

K821044 is an FDA 510(k) clearance for PATIENT PREP KITS/TRAYS-STERILE, manufactured by Phoenix Glove Co.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K821044 · Phoenix Glove Co. · General Hospital
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Jun 1982
Decision
70d
Days
Class 2
Risk

K821044 is an FDA 510(k) clearance for the PATIENT PREP KITS/TRAYS-STERILE. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Phoenix Glove Co. (Walker, US). The FDA issued a Cleared decision on June 23, 1982 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Phoenix Glove Co. devices

FDA 510(k) Submission Details - K821044

510(k) Number K821044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1982
Decision Date June 23, 1982
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - FRG Wrap, Sterilization

All 241
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K821044.
JAKOBI SURG. INSTRUMENTS #2 70/71
K834193 · Imm Enterprises , Ltd. · Feb 1984
PRO-GUARD
K830739 · Surgicot, Inc. · Mar 1983
EAGLE STERISET
K823902 · American Sterilizer Co. · Jan 1983
ECONOMY LINE OF TRAYS
K820589 · Abco Dealers, Inc. · Apr 1982
SURGIPEEL SELF-SEAL PACKAGING SYSTEM
K820302 · Surgicot, Inc. · Feb 1982
BOUNDARY STERILIZATION WRAP
K811819 · The Buckeye Cellulose Corp. · Aug 1981