Cleared Traditional

K031020 - FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE

K031020 is an FDA 510(k) clearance for FLEXISKIN LATEX EXAMINATION GLOVES, manufactured by Pt. Mandiri Inti Buana. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K031020 · Pt. Mandiri Inti Buana · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
51d
Days
Class 1
Risk

K031020 is an FDA 510(k) clearance for the FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt. Mandiri Inti Buana (Medan, ID). The FDA issued a Cleared decision on May 21, 2003 after a review of 51 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. Mandiri Inti Buana devices

FDA 510(k) Submission Details - K031020

510(k) Number K031020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2003
Decision Date May 21, 2003
Days to Decision 51 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 129d · This submission: 51d
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 600
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K031020.
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K031021 · Perusahaan Getah Asas Sdn. Bhd. · Jun 2003
NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR/APPLE/PEPPERMINT SCENTS
K030993 · Sgmp Co., Ltd. · Jun 2003
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
NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN
K030164 · Yty Industry (Manjung) Sdn Bhd · Mar 2003