Cleared Traditional

K984039 - CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESSS)

K984039 is an FDA 510(k) clearance for CRANBERRY POWDER FREE LATEX EXAMINATION..., manufactured by Cranberry (M) Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K984039 · Cranberry (M) Sdn. Bhd. · General Hospital
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Mar 1999
Decision
137d
Days
Class 1
Risk

K984039 is an FDA 510(k) clearance for the CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING .... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Cranberry (M) Sdn. Bhd. (Ipoh Perak, MY). The FDA issued a Cleared decision on March 29, 1999 after a review of 137 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 - K984039

510(k) Number K984039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1998
Decision Date March 29, 1999
Days to Decision 137 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
8d slower than avg
Panel avg: 129d · This submission: 137d
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 1363
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K984039.
ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE
K982505 · Tillotson Healthcare Corp. · Apr 1999
POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM
K990501 · Flexitech Sdn. Bhd. · Apr 1999
PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
K990502 · Flexitech Sdn. Bhd. · Apr 1999
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP
K990210 · Mexpo Intl., Inc. · Mar 1999
SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM
K990746 · Southland Products Co., Ltd. · Mar 1999
SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES
K990751 · Southland Products Co., Ltd. · Mar 1999
K984039 · CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESSS)
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