Cleared Traditional

K100895 - PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30)

K100895 is an FDA 510(k) clearance for PALM-PRO 0.30MM POWDER FREE LATEX EXAMI..., manufactured by Dipped Products Limited. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 422-day FDA review.

K100895 · Dipped Products Limited · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
422d
Days
Class 1
Risk

K100895 is an FDA 510(k) clearance for the PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Dipped Products Limited (Columbo, LK). The FDA issued a Cleared decision on May 27, 2011 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

FDA 510(k) Submission Details - K100895

510(k) Number K100895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2010
Decision Date May 27, 2011
Days to Decision 422 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
293d slower than avg
Panel avg: 129d · This submission: 422d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 1363
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K100895.
MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES
K110250 · Total Gloves Sdn Bhd · Oct 2011
LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K111158 · Innovative Gloves Co;, Ltd. · Aug 2011
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)
K111133 · Ssc Surat Thani · Jun 2011
RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR
K102902 · Rubbercare Protection Products Sdn Bhd · Apr 2011
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM
K103602 · Medline Industries, Inc. · Apr 2011
NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM
K103650 · Oon Corp. Resources · Mar 2011
K100895 · PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30)
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