Cleared Traditional

K994432 - HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)

K994432 is an FDA 510(k) clearance for HWA & SILKTEX POWDERED LATEX EXAMINATIO..., manufactured by Hwa Teh Industrial Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K994432 · Hwa Teh Industrial Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
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Feb 2000
Decision
48d
Days
Class 1
Risk

K994432 is an FDA 510(k) clearance for the HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELIN.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Hwa Teh Industrial Sdn. Bhd. (Batang Berjuntai, MY). The FDA issued a Cleared decision on February 16, 2000 after a review of 48 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 Hwa Teh Industrial Sdn. Bhd. devices

FDA 510(k) Submission Details - K994432

510(k) Number K994432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1999
Decision Date February 16, 2000
Days to Decision 48 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
81d faster than avg
Panel avg: 129d · This submission: 48d
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 582
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K994432.
MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE
K993811 · Multisafe Sdn. Bhd. · Mar 2000
SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES
K000156 · Shield Gloves Manufacturer (M) Sdn Bhd · Feb 2000
ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W
K000217 · Shield Gloves Manufacturer (M) Sdn Bhd · Feb 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION
K993918 · Pamitex Industries Sdn Bhd · Feb 2000
AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI
K993912 · Latexx Partners, Inc. · Feb 2000
POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS)
K994162 · Allegiance Healthcare Corp. · Feb 2000