Cleared Traditional

K040792 - POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)

K040792 is an FDA 510(k) clearance for POLYMER COATED, manufactured by Pt. Smartglove Indonesia. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K040792 · Pt. Smartglove Indonesia · General Hospital
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Aug 2004
Decision
136d
Days
Class 1
Risk

K040792 is an FDA 510(k) clearance for the POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt. Smartglove Indonesia (Tg Morawa-Deli Serdang Utara, ID). The FDA issued a Cleared decision on August 12, 2004 after a review of 136 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K040792

510(k) Number K040792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2004
Decision Date August 12, 2004
Days to Decision 136 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 129d · This submission: 136d
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 1120
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K040792.
PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE
K050152 · Dipped Products (Thailand), Ltd. · Feb 2005
POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING PROTEIN CONTENT CLAIM (50 MICROGRAMS OR LESS)
K043014 · Shijiazhuang Tillotson Rubber Products Co., Ltd. · Jan 2005
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE VITAMIN E AND VITAMIN C AND PROTEIN LABELING
K042645 · Qingdao Bestex Rubber & Plastic Products Co., Ltd. · Nov 2004
ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE)
K041004 · Purna Bina Sdn Bhd · Jul 2004
POWDER FREE LATEX EXAMINATION GLOVES
K033533 · Apl International Incorporated Limited · Jun 2004
POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)
K040406 · Shun Thai Rubber Gloves Industry Public Co., Ltd. · May 2004