Cleared Traditional

K990013 - EVERGREEN NON-STERILE POWDER-FREE

K990013 is an FDA 510(k) clearance for EVERGREEN NON-STERILE POWDER-FREE, manufactured by Yty Industry (Manjung) Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K990013 · Yty Industry (Manjung) Sdn Bhd · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 1999
Decision
78d
Days
Class 1
Risk

K990013 is an FDA 510(k) clearance for the EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Yty Industry (Manjung) Sdn Bhd (Crofton, US). The FDA issued a Cleared decision on March 23, 1999 after a review of 78 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 Yty Industry (Manjung) Sdn Bhd devices

FDA 510(k) Submission Details - K990013

510(k) Number K990013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1999
Decision Date March 23, 1999
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 641
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K990013.
COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE
K993313 · Wrp Asia Pacific Sdn. Bhd. · Nov 1999
COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE
K993311 · Wrp Asia Pacific Sdn. Bhd. · Nov 1999
POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
K991511 · Perusahaan Getah Asas Sdn. Bhd. · Jun 1999
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K990283 · Hartalega Sdn Bhd · Mar 1999
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED)
K984605 · Perusahaan Getah Asas Sdn. Bhd. · Jan 1999
NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP)
K984356 · Perusahaan Getah Asas Sdn. Bhd. · Jan 1999