Cleared Traditional

K992128 - DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS

K992128 is an FDA 510(k) clearance for DASH SILICONIZED POLYMER COATED POWDER ..., manufactured by Dash Medical Gloves Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K992128 · Dash Medical Gloves Sdn Bhd · General Hospital
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Sep 1999
Decision
83d
Days
Class 1
Risk

K992128 is an FDA 510(k) clearance for the DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PRO.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Dash Medical Gloves Sdn Bhd (Franklin, US). The FDA issued a Cleared decision on September 14, 1999 after a review of 83 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 - K992128

510(k) Number K992128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1999
Decision Date September 14, 1999
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 1330
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K992128.
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE
K992810 · Hwa Teh Industrial Sdn. Bhd. · Sep 1999
EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
K992175 · Ultrawin Sdn Bhd · Sep 1999
HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM 73.13 MICROGRAMS O
K992364 · Pamitex Industries Sdn Bhd · Sep 1999
QUALATEX POWDERED LATEX EXAMINATION GLOVES
K992557 · Tan Sin Lian Industries Sdn. Bhd. · Sep 1999
HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE
K992730 · Hwa Teh Industrial Sdn. Bhd. · Sep 1999
ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR
K992417 · Shield Gloves Manufacturer (M) Sdn Bhd · Sep 1999
K992128 · DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS
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