Cleared Traditional

K990746 - SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM

K990746 is an FDA 510(k) clearance for SOUTHLAND POWDERFREE LATEX EXAMINATION ..., manufactured by Southland Products Co., Ltd.. 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.

K990746 · Southland Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
15d
Days
Class 1
Risk

K990746 is an FDA 510(k) clearance for the SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Southland Products Co., Ltd. (Hatyai, Songkhla, TH). The FDA issued a Cleared decision on March 23, 1999 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 Southland Products Co., Ltd. devices

FDA 510(k) Submission Details - K990746

510(k) Number K990746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1999
Decision Date March 23, 1999
Days to Decision 15 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
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 581
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K990746.
PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
K990502 · Flexitech Sdn. Bhd. · Apr 1999
CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESSS)
K984039 · Cranberry (M) Sdn. Bhd. · Mar 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 (POLYMER-COATED) LATEX EXAMINATION GLOVES
K990751 · Southland Products Co., Ltd. · Mar 1999
NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM
K984449 · P.T. Irama Dinamika Latex · Mar 1999
LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
K990268 · La Glove (M) Sdn. Bhd. · Feb 1999