Cleared Traditional

K030164 - NON-STERILE

K030164 is an FDA 510(k) clearance for NON-STERILE, manufactured by Yty Industry (Manjung) Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K030164 · Yty Industry (Manjung) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
50d
Days
Class 1
Risk

K030164 is an FDA 510(k) clearance for the NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COL.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Yty Industry (Manjung) Sdn Bhd (Sparks, US). The FDA issued a Cleared decision on March 7, 2003 after a review of 50 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 - K030164

510(k) Number K030164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2003
Decision Date March 07, 2003
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
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 225
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K030164.
NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS
K030994 · Sgmp Co., Ltd. · Jun 2003
ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM
K030331 · Perusahaan Getah Asas Sdn. Bhd. · Mar 2003
LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM
K030333 · Perusahaan Getah Asas Sdn. Bhd. · Mar 2003
POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM
K030157 · Wrp Asia Pacific Sdn. Bhd. · Feb 2003
EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAMINATION GLOVE
K024355 · Yty Industry (Manjung) Sdn Bhd · Feb 2003
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL
K023490 · Wrp Asia Pacific Sdn. Bhd. · Jan 2003