Cleared Traditional

K894552 - 'MED-TECH' LATEX EXAMINATION GLOVE

K894552 is an FDA 510(k) clearance for 'MED-TECH' LATEX EXAMINATION GLOVE, manufactured by Med-Tech Rubber & Engineering Industries. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K894552 · Med-Tech Rubber & Engineering Industries · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
103d
Days
Class 1
Risk

K894552 is an FDA 510(k) clearance for the 'MED-TECH' LATEX EXAMINATION GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Med-Tech Rubber & Engineering Industries (Bombay, IN). The FDA issued a Cleared decision on October 31, 1989 after a review of 103 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K894552

510(k) Number K894552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date October 31, 1989
Days to Decision 103 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 129d · This submission: 103d
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 1363
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K894552.
LATEX PATIENT EXAMINATION GLOVES
K894967 · Yan Ling Rubber Products Co. · Nov 1989
PATIENT EXAMINATION GLOVES
K894352 · Rego Latex Progressive Corp. · Nov 1989
PATIENT EXAMINATION GLOVES
K894449 · Pascorp Newmarket Sdn. Bhd. · Oct 1989
S.M.P.U. LATEX EXAMINATION GLOVES
K895438 · P.T. Surya Milani Plastic Utama · Oct 1989
LATEX PATIENT EXAMINATION GLOVES
K894908 · Shanghai Shen Hua Rubber and Plastics Co. , Ltd. · Oct 1989
CITREX LATEX EXAMINATION GLOVES
K895722 · Pt Citra Latex Lestari · Oct 1989
K894552 · 'MED-TECH' LATEX EXAMINATION GLOVE
Download PDF Med-Tech Rubber & Eng…