Cleared Traditional

K982872 - TG MEDICAL POWDER-FREE LATEX EXAMINATIO...

K982872 is an FDA 510(k) clearance for TG MEDICAL POWDER-FREE LATEX EXAMINATIO..., manufactured by Tg Medical Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K982872 · Tg Medical Sdn. Bhd. · General Hospital
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Oct 1998
Decision
62d
Days
Class 1
Risk

K982872 is an FDA 510(k) clearance for the TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MIC.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Tg Medical Sdn. Bhd. (Klang, Selangor D.E., MY). The FDA issued a Cleared decision on October 15, 1998 after a review of 62 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 Tg Medical Sdn. Bhd. devices

FDA 510(k) Submission Details - K982872

510(k) Number K982872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1998
Decision Date October 15, 1998
Days to Decision 62 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 129d · This submission: 62d
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 346
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K982872.
NON-STERILE E.P. LATEX EXAMINATION GLOVE
K982453 · Ansell Perry · Nov 1998
LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
K981975 · Siam Sempermed Corp., Ltd. · Nov 1998
EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATION GLOVES: NATURAL, BLUE & PINK
K983608 · Yty Industry (Manjung) Sdn Bhd · Nov 1998
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K982806 · Perusahaan Getah Asas Sdn. Bhd. · Sep 1998
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K982807 · Perusahaan Getah Asas Sdn. Bhd. · Sep 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K980916 · Perusahaan Getah Asas Sdn. Bhd. · Aug 1998