Cleared Traditional

K990502 - PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)

K990502 is an FDA 510(k) clearance for PREPOWDERED LATEX EXAMINATION GLOVES WI..., manufactured by Flexitech Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K990502 · Flexitech Sdn. Bhd. · General Hospital
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Apr 1999
Decision
44d
Days
Class 1
Risk

K990502 is an FDA 510(k) clearance for the PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Flexitech Sdn. Bhd. (Klang, Selangor, MY). The FDA issued a Cleared decision on April 2, 1999 after a review of 44 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 Flexitech Sdn. Bhd. devices

FDA 510(k) Submission Details - K990502

510(k) Number K990502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1999
Decision Date April 02, 1999
Days to Decision 44 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
85d faster than avg
Panel avg: 129d · This submission: 44d
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 580
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K990502.
BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
K990543 · Brightway Holdings Sdn. Bhd. · Apr 1999
ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE
K982505 · Tillotson Healthcare Corp. · Apr 1999
POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM
K990501 · Flexitech Sdn. Bhd. · Apr 1999
CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESSS)
K984039 · Cranberry (M) Sdn. Bhd. · Mar 1999
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP
K990210 · Mexpo Intl., Inc. · Mar 1999
SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM
K990746 · Southland Products Co., Ltd. · Mar 1999