Cleared Special

K001141 - POWDER FREE STERILE LATEX EXAMINATION GLOVES (FDA 510(k) Clearance)

Class I General Hospital device.

K001141 · Allegiance Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
29d
Days
Class 1
Risk

K001141 is an FDA 510(k) clearance for the POWDER FREE STERILE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on May 9, 2000 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Allegiance Healthcare Corp. devices

Submission Details

510(k) Number K001141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date May 09, 2000
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 128d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K001141.
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
K250069 · Comfort Rubber Gloves Industries Sdn. Bhd. · Apr 2025
Latex Examination Glove Powder Free (Ocean Blue and Natural White)
K240266 · Sri Trang Gloves (Thailand) Public Company Limited · Sep 2024
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
K230573 · Kossan International Sdn Bhd · Jun 2023
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
K223298 · Shandong Intco Medical Products Co, Ltd. · Feb 2023
Powder-Free Latex examination gloves
K222612 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Nov 2022
Non Sterile Powder Free Latex Examination Glove
K221667 · New Era Medicare Sdn. Bhd. · Oct 2022