Cleared Traditional

K013996 - LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE

K013996 is an FDA 510(k) clearance for LATEX POWDERFREE STERILE EXAMINATION GLOVES, manufactured by Pt. Maja Agung Latexindo. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K013996 · Pt. Maja Agung Latexindo · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
85d
Days
Class 1
Risk

K013996 is an FDA 510(k) clearance for the LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIU.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt. Maja Agung Latexindo (Chino, US). The FDA issued a Cleared decision on February 26, 2002 after a review of 85 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 Pt. Maja Agung Latexindo devices

FDA 510(k) Submission Details - K013996

510(k) Number K013996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2001
Decision Date February 26, 2002
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 802
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K013996.
SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHIT
K014110 · Siam Sempermed Corp., Ltd. · Feb 2002
SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E
K014112 · Siam Sempermed Corp., Ltd. · Feb 2002
AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM
K013953 · Supermax Glove Manufacturing Sdn Bhd · Feb 2002
NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING
K014055 · Seal Polymer Industries Bhd. · Jan 2002
UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES
K013163 · N.S. Uni-Gloves Sdn. Bhd. · Jan 2002
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
K013262 · Great Glove (Thailand) Co. , Ltd. · Jan 2002