Cleared Traditional

K021536 - DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR

K021536 is an FDA 510(k) clearance for DERMAGRIP AND MULTIPLE POWDER FREE LATE..., 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 31-day FDA review.

K021536 · 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
Jun 2002
Decision
31d
Days
Class 1
Risk

K021536 is an FDA 510(k) clearance for the DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Wrp Specialty Products Sdn. Bhd. (Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on June 10, 2002 after a review of 31 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 - K021536

510(k) Number K021536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2002
Decision Date June 10, 2002
Days to Decision 31 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
98d faster than avg
Panel avg: 129d · This submission: 31d
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 K021536.
STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES
K021521 · Smart Glove Corp. Sdn Bhd · Jul 2002
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O
K021561 · Wrp Specialty Products Sdn. Bhd. · Jun 2002
CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM
K021388 · Seal Polymer Industries Bhd. · Jun 2002
LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED
K021412 · Arista Latindo Industrial Ltd. P.T · Jun 2002
SAFE SHIELD PRE-POWDERED LATEX EXAMINATION GLOVES
K013980 · Safe Shield Co., Ltd. · Jun 2002
MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
K021465 · Industrial Clothings, Ltd. · May 2002