Cleared Traditional

K000971 - PROFEEL POWDER FREE NITRILE SURGICAL GLOVE

K000971 is the FDA 510(k) clearance for PROFEEL POWDER FREE NITRILE SURGICAL GLOVE by Wrp Asia Pacific Sdn. Bhd.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K000971 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
18d
Days
Class 1
Risk

K000971 is an FDA 510(k) clearance for the PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Wrp Asia Pacific Sdn. Bhd. (Salak Tinggi, Sepang Selangor, MY). The FDA issued a Cleared decision on April 14, 2000 after a review of 18 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - 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 Asia Pacific Sdn. Bhd. devices

Submission Details

510(k) Number K000971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2000
Decision Date April 14, 2000
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, 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 - KGO Surgeon's Gloves

All 164
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K000971.
PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE
K003019 · Wrp Asia Pacific Sdn. Bhd. · Nov 2000
POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
K001959 · Hartalega Sdn Bhd · Jul 2000
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0
K001924 · Allegiance Healthcare Corp. · Jul 2000
ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K991205 · Allegiance Healthcare Corp. · Oct 1999
COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K992171 · Allegiance Healthcare Corp. · Sep 1999
ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES
K991992 · Allegiance Healthcare Corp. · Jul 1999