Cleared Traditional

K982611 - UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE)

K982611 is an FDA 510(k) clearance for UNIJECT LATEX EXAMINATION GLOVES (POWDE..., manufactured by Uniject Gloves Pcl. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K982611 · Uniject Gloves Pcl · General Hospital
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Nov 1998
Decision
129d
Days
Class 1
Risk

K982611 is an FDA 510(k) clearance for the UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Uniject Gloves Pcl (Chalmette, US). The FDA issued a Cleared decision on November 2, 1998 after a review of 129 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Uniject Gloves Pcl devices

FDA 510(k) Submission Details - K982611

510(k) Number K982611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1998
Decision Date November 02, 1998
Days to Decision 129 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
At panel average
Panel avg: 129d · This submission: 129d
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 478
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K982611.
LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
K981975 · Siam Sempermed Corp., Ltd. · Nov 1998
EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATION GLOVES: NATURAL, BLUE & PINK
K983608 · Yty Industry (Manjung) Sdn Bhd · Nov 1998
LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED
K981600 · Young Innovations, LLC Dba Plak Smacker · Nov 1998
TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K982872 · Tg Medical Sdn. Bhd. · Oct 1998
EXTRA-CARE POWDER-FREE EXAMINATION GLOVE
K983175 · Ultrawin Sdn Bhd · Oct 1998
MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
K982691 · Perusahaan Intan Emas Sdn. Bhd. · Oct 1998