Cleared Traditional

K994131 - AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50 MICROGRAMS OR LESS PER GRAM (BLACK COLORED)

K994131 is an FDA 510(k) clearance for AMBIDERM POWDERFREE LATEX EXAMINATION G..., manufactured by Medtaxx Partners. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K994131 · Medtaxx Partners · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
62d
Days
Class 1
Risk

K994131 is an FDA 510(k) clearance for the AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50 MICRO.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Medtaxx Partners (Crofton, US). The FDA issued a Cleared decision on February 7, 2000 after a review of 62 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 Medtaxx Partners devices

FDA 510(k) Submission Details - K994131

510(k) Number K994131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1999
Decision Date February 07, 2000
Days to Decision 62 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 129d · This submission: 62d
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 582
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K994131.
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION
K993918 · Pamitex Industries Sdn Bhd · Feb 2000
AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI
K993912 · Latexx Partners, Inc. · Feb 2000
POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS)
K994162 · Allegiance Healthcare Corp. · Feb 2000
RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K994201 · Perusahaan Pelindung Getah (M) Sdn Bhd · Feb 2000
TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K994250 · Tekmedic (M) Sdn Bhd · Feb 2000
LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE
K994255 · Pt. Maja Agung Latexindo · Feb 2000