Cleared Traditional

K974065 - POWDER FREE HYPROALLERGENIC EXAMINATION...

K974065 is an FDA 510(k) clearance for POWDER FREE HYPROALLERGENIC EXAMINATION..., manufactured by Tillotson Healthcare Corp.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K974065 · Tillotson Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
71d
Days
Class 1
Risk

K974065 is an FDA 510(k) clearance for the POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Tillotson Healthcare Corp. (Bedford, US). The FDA issued a Cleared decision on January 6, 1998 after a review of 71 days - a notably fast clearance cycle.

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: 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 Tillotson Healthcare Corp. devices

FDA 510(k) Submission Details - K974065

510(k) Number K974065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1997
Decision Date January 06, 1998
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
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 294
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K974065.
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
K980037 · Sri Johani Sdn. Bhd. · Feb 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES
K980038 · Sri Johani Sdn. Bhd. · Feb 1998
POWDERED GREEN LATEX EXAMINATION GLOVES
K980039 · Sri Johani Sdn. Bhd. · Feb 1998
EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE
K974191 · Yty Industry (Manjung) Sdn Bhd · Dec 1997
HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR)
K974184 · Sri Johani Sdn. Bhd. · Dec 1997
DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES
K974218 · Ansell Perry · Dec 1997