Cleared Traditional

K971403 - SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE

K971403 is an FDA 510(k) clearance for SMART - GLOVE POWDER FREE LATEX EXAMINA..., manufactured by Sj Medical Products (M) Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K971403 · Sj Medical Products (M) Sdn Bhd · General Hospital
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May 1997
Decision
44d
Days
Class 1
Risk

K971403 is an FDA 510(k) clearance for the SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Sj Medical Products (M) Sdn Bhd (Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on May 29, 1997 after a review of 44 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 Sj Medical Products (M) Sdn Bhd devices

FDA 510(k) Submission Details - K971403

510(k) Number K971403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1997
Decision Date May 29, 1997
Days to Decision 44 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
85d faster than avg
Panel avg: 129d · This submission: 44d
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 439
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K971403.
LOW PROTEIN LATEX EXAMINATION GLOVES
K970222 · Kossan Latex Industries(M)Sdn Bhd · Jun 1997
POWDER-FREE LATEX EXAMINATION GLOVES
K964724 · Pwa Industries Sdn. Bhd. · Jun 1997
DERMACLEAN X-AM (PROTEIN LABELING CLAIM) EXAMINATION GLOVES
K971424 · Ansell Perry · Jun 1997
LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)
K970794 · Siam Sempermed Corp., Ltd. · May 1997
SAFESKIN POWDERED EXAMINATION GLOVE
K970899 · Safeskin Corp. · May 1997
POLY-MED
K970625 · Shinemound Enterprise, Inc. · Mar 1997