Cleared Traditional

K970191 - UNIJECT EXAMINATION GLOVES

K970191 is an FDA 510(k) clearance for UNIJECT EXAMINATION GLOVES, manufactured by Uniject Gloves , Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K970191 · Uniject Gloves , Ltd. · General Hospital
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Jul 1997
Decision
168d
Days
Class 1
Risk

K970191 is an FDA 510(k) clearance for the UNIJECT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Uniject Gloves , Ltd. (Chalmette, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 168 days - an extended review 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: 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 , Ltd. devices

FDA 510(k) Submission Details - K970191

510(k) Number K970191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1997
Decision Date July 03, 1997
Days to Decision 168 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
39d slower than avg
Panel avg: 129d · This submission: 168d
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 439
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K970191.
POWDER-FREE PATIENT EXAMINATION GLOVES
K971949 · Tekmedic (M) Sdn Bhd · Jul 1997
ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES
K972291 · Allegiance Healthcare Corp. · Jul 1997
LATEX EXAMINATION GLOVES
K970770 · Oon Corp. Resources · Jul 1997
LATEX EXAMINATION GLOVES, POWDER FREE
K970977 · Arista Medi Prima · Jun 1997
POWDER - FREE LATEX EXAMINATION GLOVES APPLICATION
K964826 · Kossan Latex Industries(M)Sdn Bhd · Jun 1997
LOW PROTEIN LATEX EXAMINATION GLOVES
K970222 · Kossan Latex Industries(M)Sdn Bhd · Jun 1997