Cleared Traditional

K992675 - PATIENT NITRILE EXAMINATION GLOVES (POWDERED)

K992675 is an FDA 510(k) clearance for PATIENT NITRILE EXAMINATION GLOVES (POW..., manufactured by Wear Safe Malaysia Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K992675 · Wear Safe Malaysia Sdn. Bhd. · General Hospital
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Jan 2000
Decision
163d
Days
Class 1
Risk

K992675 is an FDA 510(k) clearance for the PATIENT NITRILE EXAMINATION GLOVES (POWDERED). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Wear Safe Malaysia Sdn. Bhd. (Port Klang, Selangor, D.E., MY). The FDA issued a Cleared decision on January 20, 2000 after a review of 163 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K992675

510(k) Number K992675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1999
Decision Date January 20, 2000
Days to Decision 163 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 129d · This submission: 163d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 1176
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K992675.
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K993876 · Shen Wei (Usa), Inc. · Feb 2000
OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
K994246 · Omnigrace , Ltd. · Jan 2000
BLUE NITRILE EXAMINATION GLOVES - POWDER FREE
K994064 · Glove Source, Inc. · Jan 2000
MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE)
K993127 · Glovesworld Industries Sdn. Bhd. · Dec 1999
COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE
K993313 · Wrp Asia Pacific Sdn. Bhd. · Nov 1999
COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE
K993311 · Wrp Asia Pacific Sdn. Bhd. · Nov 1999