Cleared Traditional

K944139 - DENTAL HYGIENE TRAY

K944139 is an FDA 510(k) clearance for DENTAL HYGIENE TRAY, manufactured by Sterile Concepts, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K944139 · Sterile Concepts, Inc. · General Hospital
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Dec 1994
Decision
113d
Days
Class 1
Risk

K944139 is an FDA 510(k) clearance for the DENTAL HYGIENE TRAY. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Sterile Concepts, Inc. (Richmond, US). The FDA issued a Cleared decision on December 15, 1994 after a review of 113 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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 Sterile Concepts, Inc. devices

FDA 510(k) Submission Details - K944139

510(k) Number K944139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1994
Decision Date December 15, 1994
Days to Decision 113 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
16d faster than avg
Panel avg: 129d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LYY Latex Patient Examination Glove

All 667
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K944139.
SCIPOTEX
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K945247 · Sri Johani Sdn. Bhd. · Jan 1995
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K932521 · Top Glove Sdn. Bhd. · Dec 1994
LATEX MEDICAL GLOVE
K943900 · Johnson & Johnson Medical, Inc. · Dec 1994
COMFIT BLUE POWDERED EXAMINATION GLOVES
K936268 · Wembley Rubber Products (M) Sdn Bhd · Dec 1994