Cleared Traditional

K974853 - LATEX (POWDER FREE) LOW PROTEIN

K974853 is an FDA 510(k) clearance for LATEX (POWDER FREE) LOW PROTEIN, manufactured by P.T. Healthcare Glovindo. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K974853 · P.T. Healthcare Glovindo · General Hospital
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Feb 1998
Decision
42d
Days
Class 1
Risk

K974853 is an FDA 510(k) clearance for the LATEX (POWDER FREE) LOW PROTEIN. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by P.T. Healthcare Glovindo (Jakarta, ID). The FDA issued a Cleared decision on February 9, 1998 after a review of 42 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 P.T. Healthcare Glovindo devices

FDA 510(k) Submission Details - K974853

510(k) Number K974853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1997
Decision Date February 09, 1998
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 294
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K974853.
POWDERFREE LATEX EXAMINATION GLOVES
K980194 · Besglove Medicare Sdn. Bhd. · Mar 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
K980572 · Hartalega Sdn Bhd · Mar 1998
POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)
K980318 · Hartalega Sdn Bhd · Mar 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
K980037 · Sri Johani Sdn. Bhd. · Feb 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES
K980038 · Sri Johani Sdn. Bhd. · Feb 1998
POWDERED GREEN LATEX EXAMINATION GLOVES
K980039 · Sri Johani Sdn. Bhd. · Feb 1998