Cleared Traditional

K102790 - POWDER FREE NITRILE PATIENT EXAMINATION...

K102790 is the FDA 510(k) clearance for POWDER FREE NITRILE PATIENT EXAMINATION... by Perusahaan Getah Asas Sdn. Bhd.. It is a Class 1 General Hospital device (product code LZC) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K102790 · Perusahaan Getah Asas Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
63d
Days
Class 1
Risk

K102790 is an FDA 510(k) clearance for the POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW .... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Perusahaan Getah Asas Sdn. Bhd. (Klang, Selangor, MY). The FDA issued a Cleared decision on November 29, 2010 after a review of 63 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 Perusahaan Getah Asas Sdn. Bhd. devices

Submission Details

510(k) Number K102790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2010
Decision Date November 29, 2010
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
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 - LZC Medical Glove, Specialty

All 41
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K102790.
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POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K083408 · Wrp Asia Pacific Sdn. Bhd. · Jul 2009
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM
K083410 · Wrp Asia Pacific Sdn. Bhd. · Jul 2009