Cleared Traditional

K003132 - DERMAGRIP POWDER FREE BLUE POLYMER COAT...

K003132 is an FDA 510(k) clearance for DERMAGRIP POWDER FREE BLUE POLYMER COAT..., 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 42-day FDA review.

K003132 · Wrp Specialty Products Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
42d
Days
Class 1
Risk

K003132 is an FDA 510(k) clearance for the DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERIL.... 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 November 17, 2000 after a review of 42 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 Wrp Specialty Products Sdn. Bhd. devices

FDA 510(k) Submission Details - K003132

510(k) Number K003132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2000
Decision Date November 17, 2000
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 382
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K003132.
NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
K003547 · Terang Nusa Sdn Bhd · Dec 2000
DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL W
K003307 · Wrp Specialty Products Sdn. Bhd. · Nov 2000
DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
K003309 · Wrp Specialty Products Sdn. Bhd. · Nov 2000
FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO
K002720 · Tillotson Healthcare Corp. · Nov 2000
DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABL
K002975 · Wrp Specialty Products Sdn. Bhd. · Oct 2000
POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K002568 · Smart Glove Corp. Sdn Bhd · Oct 2000