Cleared Abbreviated

K100907 - NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL

K100907 is an FDA 510(k) clearance for NON-STERILE, manufactured by Siam Sempermed Corp., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Abbreviated 510(k) pathway after a 99-day FDA review.

K100907 · Siam Sempermed Corp., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
99d
Days
Class 1
Risk

K100907 is an FDA 510(k) clearance for the NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICRO.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Siam Sempermed Corp., Ltd. (Clearwater, US). The FDA issued a Cleared decision on July 9, 2010 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K100907

510(k) Number K100907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2010
Decision Date July 09, 2010
Days to Decision 99 days
Submission Type Abbreviated
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
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Standards-based clearance path.

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 1238
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K100907.
POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE
K101799 · Wear Safe Malaysia Sdn. Bhd. · Sep 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
COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN
K100694 · Tekmedic (M) Sdn Bhd · Jun 2010
LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET)
K093193 · La Glove (M) Sdn. Bhd. · Jun 2010
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA
K100211 · Shen Wei (Usa), Inc. · May 2010
K100907 · NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
Download PDF FDA Summary Siam Sempermed Corp.,…