Cleared Traditional

K992337 - BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA

K992337 is an FDA 510(k) clearance for BLOSSOM POWDER FREE LATEX EXAMINATION G..., manufactured by Mexpo Intl., Inc.. The device is a Class 1 General Hospital device with product code FMC cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K992337 · Mexpo Intl., Inc. · General Hospital
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Aug 1999
Decision
35d
Days
Class 1
Risk

K992337 is an FDA 510(k) clearance for the BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CL.... Classified as Patient Examination Glove (product code FMC), Class I - General Controls.

Submitted by Mexpo Intl., Inc. (Hayward,, US). The FDA issued a Cleared decision on August 17, 1999 after a review of 35 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 - K992337

510(k) Number K992337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1999
Decision Date August 17, 1999
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

FMC Device Classification - Class 1, General Controls

Product Code FMC Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
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 - FMC Patient Examination Glove

All 15
Devices cleared under the same product code (FMC) and FDA review panel - the closest regulatory comparables to K992337.
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K923175 · Ulti-Med Intl., Inc. · Jun 1993
COMFIT, PATIENT EXAMINATION GLOVES
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K883805 · A & A Medical, Inc. · Jan 1989