Cleared Traditional

K983175 - EXTRA-CARE POWDER-FREE EXAMINATION GLOVE

K983175 is an FDA 510(k) clearance for EXTRA-CARE POWDER-FREE EXAMINATION GLOVE, manufactured by Ultrawin Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K983175 · Ultrawin Sdn Bhd · General Hospital
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Oct 1998
Decision
33d
Days
Class 1
Risk

K983175 is an FDA 510(k) clearance for the EXTRA-CARE POWDER-FREE EXAMINATION GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Ultrawin Sdn Bhd (Chemor, Perak, MY). The FDA issued a Cleared decision on October 13, 1998 after a review of 33 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 Ultrawin Sdn Bhd devices

FDA 510(k) Submission Details - K983175

510(k) Number K983175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1998
Decision Date October 13, 1998
Days to Decision 33 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
96d faster than avg
Panel avg: 129d · This submission: 33d
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 477
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K983175.
LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED
K981600 · Young Innovations, LLC Dba Plak Smacker · Nov 1998
UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE)
K982611 · Uniject Gloves Pcl · Nov 1998
TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K982872 · Tg Medical 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
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K982806 · Perusahaan Getah Asas Sdn. Bhd. · Sep 1998
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K982807 · Perusahaan Getah Asas Sdn. Bhd. · Sep 1998