Cleared Traditional

K994416 - POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

K994416 is an FDA 510(k) clearance for POLYMER COATED POWDER FREE NITRILE EXAM..., 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 36-day FDA review.

K994416 · Flexitech Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
36d
Days
Class 1
Risk

K994416 is an FDA 510(k) clearance for the POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE. 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 February 3, 2000 after a review of 36 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 - K994416

510(k) Number K994416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1999
Decision Date February 03, 2000
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
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 K994416.
RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K994201 · Perusahaan Pelindung Getah (M) Sdn Bhd · Feb 2000
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, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K994354 · Flexitech Sdn. Bhd. · Jan 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