Cleared Traditional

K992841 - TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES

K992841 is an FDA 510(k) clearance for TG MEDICAL POWDERED NITRILE BLUE EXAMIN..., manufactured by Tg Medical Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K992841 · Tg Medical Sdn. Bhd. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 1999
Decision
66d
Days
Class 1
Risk

K992841 is an FDA 510(k) clearance for the TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Tg Medical Sdn. Bhd. (Klang, Selangor D.E., MY). The FDA issued a Cleared decision on October 29, 1999 after a review of 66 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 - K992841

510(k) Number K992841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1999
Decision Date October 29, 1999
Days to Decision 66 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
63d faster than avg
Panel avg: 129d · This submission: 66d
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 K992841.
QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED
K992924 · Latexx Partners Bhd. · Nov 1999
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K993247 · Jda Intl., Inc. · Nov 1999
INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE
K993325 · Innovative Gloves Co;, Ltd. · Nov 1999
SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE
K992830 · Safeskin Corp. · Oct 1999
SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES
K993258 · Supermax Sdn Bhd · Oct 1999
DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE
K990752 · Wrp Specialty Products Sdn. Bhd. · Oct 1999