Cleared Traditional

K892100 - PATIENT EXAM GLOVES (MFG. SHUN JUN TRADING CO.)

K892100 is an FDA 510(k) clearance for PATIENT EXAM GLOVES (MFG. SHUN JUN TRAD..., manufactured by Ergo Intl., Ent., Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K892100 · Ergo Intl., Ent., Inc. · General Hospital
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May 1989
Decision
35d
Days
Class 1
Risk

K892100 is an FDA 510(k) clearance for the PATIENT EXAM GLOVES (MFG. SHUN JUN TRADING CO.). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Ergo Intl., Ent., Inc. (North Miami Beach, US). The FDA issued a Cleared decision on May 8, 1989 after a review of 35 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 Ergo Intl., Ent., Inc. devices

FDA 510(k) Submission Details - K892100

510(k) Number K892100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1989
Decision Date May 08, 1989
Days to Decision 35 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 129d · This submission: 35d
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 732
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K892100.
PATIENT EXAMINATION GLOVES (LATEX)(POWDERED)
K891640 · Perusahaan Getah Asas Sdn. Bhd. · May 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891417 · Kossan Latex Industries(M)Sdn Bhd · May 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891435 · Safeskin Corp. · May 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892086 · Cypress Medical Products, Ltd. · May 1989
NON-STERILE LATEX EXAMINATION GLOVES
K891441 · Arista Latindo Industrial Ltd. P.T · Apr 1989
CURITY DISPOSABLE LATEX GLOVES
K891255 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1989