Cleared Traditional

K990268 - LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)

K990268 is an FDA 510(k) clearance for LAGLOVE BRAND POLYMER COATED LATEX EXAM..., manufactured by La Glove (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 27-day FDA review.

K990268 · La Glove (M) Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
27d
Days
Class 1
Risk

K990268 is an FDA 510(k) clearance for the LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by La Glove (M) Sdn. Bhd. (Kajang Selangpr D.E., MY). The FDA issued a Cleared decision on February 24, 1999 after a review of 27 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 La Glove (M) Sdn. Bhd. devices

FDA 510(k) Submission Details - K990268

510(k) Number K990268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1999
Decision Date February 24, 1999
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
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 612
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K990268.
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
NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM
K984449 · P.T. Irama Dinamika Latex · Mar 1999
GUTHRIE PRIME POWDER-FREE
K990228 · Guthrie Medicare Products (Melaka) Sdn Bhd · Feb 1999
LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE)
K990270 · La Glove (M) Sdn. Bhd. · Feb 1999
LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN)
K990285 · La Glove (M) Sdn. Bhd. · Feb 1999