Cleared Traditional

K011922 - POWDERED LATEX EXAMINATION GLOVES

K011922 is an FDA 510(k) clearance for POWDERED LATEX EXAMINATION GLOVES, manufactured by Seltom Pacific Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K011922 · Seltom Pacific Sdn. Bhd. · General Hospital
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Jul 2001
Decision
15d
Days
Class 1
Risk

K011922 is an FDA 510(k) clearance for the POWDERED LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Seltom Pacific Sdn. Bhd. (Petaling Jaya, Selangor, MY). The FDA issued a Cleared decision on July 5, 2001 after a review of 15 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 Seltom Pacific Sdn. Bhd. devices

FDA 510(k) Submission Details - K011922

510(k) Number K011922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2001
Decision Date July 05, 2001
Days to Decision 15 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 129d · This submission: 15d
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 613
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K011922.
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
K011045 · Shen Wei (Usa), Inc. · Sep 2001
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
K011044 · Shen Wei (Usa), Inc. · Sep 2001
BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (
K011728 · Brightway Holdings Sdn. Bhd. · Jul 2001
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG
K011370 · Sgmp Co., Ltd. · Jun 2001
NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW
K011371 · Sgmp Co., Ltd. · Jun 2001
NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5
K011377 · Sgmp Co., Ltd. · Jun 2001