Cleared Traditional

K971424 - DERMACLEAN X-AM (PROTEIN LABELING CLAIM...

K971424 is an FDA 510(k) clearance for DERMACLEAN X-AM (PROTEIN LABELING CLAIM..., manufactured by Ansell Perry. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K971424 · Ansell Perry · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
47d
Days
Class 1
Risk

K971424 is an FDA 510(k) clearance for the DERMACLEAN X-AM (PROTEIN LABELING CLAIM) EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Ansell Perry (Massillon, US). The FDA issued a Cleared decision on June 4, 1997 after a review of 47 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 Ansell Perry devices

FDA 510(k) Submission Details - K971424

510(k) Number K971424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1997
Decision Date June 04, 1997
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
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 292
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K971424.
CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVES
K972785 · Ansell Perry · Sep 1997
PATIENT LATEX EXAMINATION GLOVE (PREPOWDERED)
K971629 · Besglove Medicare Sdn. Bhd. · Aug 1997
ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES
K972291 · Allegiance Healthcare Corp. · Jul 1997
LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)
K970794 · Siam Sempermed Corp., Ltd. · May 1997
SAFESKIN POWDERED EXAMINATION GLOVE
K970899 · Safeskin Corp. · May 1997
MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
K962096 · Medline Industries, Inc. · Nov 1996