Cleared Traditional

K992175 - EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED

K992175 is an FDA 510(k) clearance for EXTRA-CARE LATEX PATIENT 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 88-day FDA review.

K992175 · Ultrawin Sdn Bhd · General Hospital
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Sep 1999
Decision
88d
Days
Class 1
Risk

K992175 is an FDA 510(k) clearance for the EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED. 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 September 24, 1999 after a review of 88 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.

FDA 510(k) Submission Details - K992175

510(k) Number K992175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1999
Decision Date September 24, 1999
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 1363
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K992175.
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATION GLOVE, (NATURAL LATEX LAMINATED WITH NITRILE, EXTERNA
K991474 · Pamitex Industries Sdn Bhd · Oct 1999
PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER
K992117 · Pamitex Industries Sdn Bhd · Sep 1999
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE
K992810 · Hwa Teh Industrial Sdn. Bhd. · Sep 1999
HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM 73.13 MICROGRAMS O
K992364 · Pamitex Industries Sdn Bhd · Sep 1999
DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS
K992128 · Dash Medical Gloves Sdn Bhd · Sep 1999
QUALATEX POWDERED LATEX EXAMINATION GLOVES
K992557 · Tan Sin Lian Industries Sdn. Bhd. · Sep 1999
K992175 · EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
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