Cleared Traditional

K994354 - POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

K994354 is an FDA 510(k) clearance for POLYMER COATED, 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 39-day FDA review.

K994354 · Flexitech Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
39d
Days
Class 1
Risk

K994354 is an FDA 510(k) clearance for the POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LA.... 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 January 31, 2000 after a review of 39 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 - K994354

510(k) Number K994354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1999
Decision Date January 31, 2000
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 566
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K994354.
TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K994250 · Tekmedic (M) Sdn Bhd · Feb 2000
LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE
K994255 · Pt. Maja Agung Latexindo · Feb 2000
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K994416 · Flexitech Sdn. Bhd. · Feb 2000
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS)
K994082 · Besglove Medicare Sdn. Bhd. · Jan 2000
COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES
K993864 · Supermax Sdn Bhd · Jan 2000
GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
K993865 · Supermax Sdn Bhd · Jan 2000