Cleared Traditional

K970794 - LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)

K970794 is an FDA 510(k) clearance for LATEX PATIENT EXAMINATION (POWDERFREE G..., manufactured by Siam Sempermed Corp., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K970794 · Siam Sempermed Corp., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
63d
Days
Class 1
Risk

K970794 is an FDA 510(k) clearance for the LATEX PATIENT EXAMINATION (POWDERFREE GLOVE). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Siam Sempermed Corp., Ltd. (Hatyai, Songkhla, TH). The FDA issued a Cleared decision on May 6, 1997 after a review of 63 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 Siam Sempermed Corp., Ltd. devices

FDA 510(k) Submission Details - K970794

510(k) Number K970794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1997
Decision Date May 06, 1997
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
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 402
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K970794.
POWDER - FREE LATEX EXAMINATION GLOVES APPLICATION
K964826 · Kossan Latex Industries(M)Sdn Bhd · Jun 1997
LOW PROTEIN LATEX EXAMINATION GLOVES
K970222 · Kossan Latex Industries(M)Sdn Bhd · Jun 1997
DERMACLEAN X-AM (PROTEIN LABELING CLAIM) EXAMINATION GLOVES
K971424 · Ansell Perry · Jun 1997
SAFESKIN POWDERED EXAMINATION GLOVE
K970899 · Safeskin Corp. · May 1997
MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
K962096 · Medline Industries, Inc. · Nov 1996
TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE
K960590 · Aladan Corp. · Oct 1996