Cleared Traditional

K992681 - PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE

K992681 is an FDA 510(k) clearance for PATIENT LATEX EXAMINATION GLOVE POWDERE..., 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 128-day FDA review.

K992681 · Wear Safe Malaysia Sdn. Bhd. · General Hospital
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Dec 1999
Decision
128d
Days
Class 1
Risk

K992681 is an FDA 510(k) clearance for the PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Wear Safe Malaysia Sdn. Bhd. (Port Klang, Selangor, D.E., MY). The FDA issued a Cleared decision on December 16, 1999 after a review of 128 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 - K992681

510(k) Number K992681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1999
Decision Date December 16, 1999
Days to Decision 128 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
1d faster than avg
Panel avg: 129d · This submission: 128d
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 K992681.
GREEN POWDERED LATEX EXAMINATION GLOVES
K993452 · Top Glove Sdn. Bhd. · Dec 1999
PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES
K993605 · Top Glove Sdn. Bhd. · Dec 1999
PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES
K992676 · Wear Safe Malaysia Sdn. Bhd. · Dec 1999
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS)
K993454 · Sri Johani Sdn. Bhd. · Dec 1999
GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K993752 · Glovco (M) Sdn. Bhd. · Dec 1999
QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS
K993271 · Quality Latex Corp. Sdn Bhd · Dec 1999