Cleared Traditional

K990210 - POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP

K990210 is an FDA 510(k) clearance for POWDERED LATEX EXAMINATION GLOVES WITH ..., manufactured by Mexpo Intl., Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K990210 · Mexpo Intl., Inc. · General Hospital
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Mar 1999
Decision
67d
Days
Class 1
Risk

K990210 is an FDA 510(k) clearance for the POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MI.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Mexpo Intl., Inc. (Hayward,, US). The FDA issued a Cleared decision on March 29, 1999 after a review of 67 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 Mexpo Intl., Inc. devices

FDA 510(k) Submission Details - K990210

510(k) Number K990210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1999
Decision Date March 29, 1999
Days to Decision 67 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 129d · This submission: 67d
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 487
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K990210.
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
CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESSS)
K984039 · Cranberry (M) Sdn. Bhd. · Mar 1999
NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM
K984449 · P.T. Irama Dinamika Latex · Mar 1999
LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
K990268 · La Glove (M) Sdn. Bhd. · Feb 1999
LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE)
K990270 · La Glove (M) Sdn. Bhd. · Feb 1999