Cleared Traditional

K991044 - DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING)

K991044 is an FDA 510(k) clearance for DERMAGRIP POWDER FREE LATEX EXAMINATION..., manufactured by Wrp Specialty Products Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K991044 · Wrp Specialty Products Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
24d
Days
Class 1
Risk

K991044 is an FDA 510(k) clearance for the DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT L.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Wrp Specialty Products Sdn. Bhd. (Selangor Daurl Ehsan, Sepang, MY). The FDA issued a Cleared decision on April 23, 1999 after a review of 24 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.

FDA 510(k) Submission Details - K991044

510(k) Number K991044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1999
Decision Date April 23, 1999
Days to Decision 24 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 129d · This submission: 24d
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 K991044.
LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING
K990468 · Top Glove Sdn. Bhd. · Apr 1999
KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K990526 · Ssn Gloves (M) Sdn Bhd · Apr 1999
KLEENHANDS POWDERED LATEX EXAMINATION GLOVES
K990527 · Ssn Gloves (M) Sdn Bhd · Apr 1999
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE)
K990539 · Brightway Holdings Sdn. Bhd. · Apr 1999
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN)
K990540 · Brightway Holdings Sdn. Bhd. · Apr 1999
BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
K990543 · Brightway Holdings Sdn. Bhd. · Apr 1999