Cleared Traditional

K974223 - NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES

K974223 is an FDA 510(k) clearance for NITRILE, manufactured by Derlin Company , Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K974223 · Derlin Company , Ltd. · General Hospital
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Dec 1997
Decision
36d
Days
Class 1
Risk

K974223 is an FDA 510(k) clearance for the NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Derlin Company , Ltd. (Waukegan, US). The FDA issued a Cleared decision on December 18, 1997 after a review of 36 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 Derlin Company , Ltd. devices

FDA 510(k) Submission Details - K974223

510(k) Number K974223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1997
Decision Date December 18, 1997
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 778
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K974223.
DASH, VITAL GARD
K974114 · Dash Medical Gloves Sdn Bhd · Dec 1997
POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K974183 · Sri Johani Sdn. Bhd. · Dec 1997
POLYMER NITRILE EXAMINATION GLOVES
K974185 · Sri Johani Sdn. Bhd. · Dec 1997
POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K973903 · Sri Johani Sdn. Bhd. · Dec 1997
POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K974182 · Sri Johani Sdn. Bhd. · Dec 1997
PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE)
K973058 · Sri Johani Sdn. Bhd. · Nov 1997