Cleared Traditional

K101799 - POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE

K101799 is an FDA 510(k) clearance for POWDER FREE LATEX EXAMINATION GLOVES BL..., manufactured by Wear Safe Malaysia Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K101799 · Wear Safe Malaysia Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
67d
Days
Class 1
Risk

K101799 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEI.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Wear Safe Malaysia Sdn. Bhd. (Klang, Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on September 3, 2010 after a review of 67 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.

FDA 510(k) Submission Details - K101799

510(k) Number K101799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2010
Decision Date September 03, 2010
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
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 1134
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K101799.
POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1
K101106 · Best Putra Gloves Sdn Bhd · Nov 2010
COMFORT RUBBER GLOVES IND.SDN.BHD.
K101917 · Comfort Rubber Gloves Industries Sdn. Bhd. · Oct 2010
POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K101828 · Gx Corporation Sdn Bhd · Oct 2010
NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF
K101645 · Latexx Manufacturing Sdn.Bhd. · Aug 2010
RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)
K100611 · Riverstone Resources Sdn Bhd · Jul 2010
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
K100907 · Siam Sempermed Corp., Ltd. · Jul 2010