Cleared Traditional

K974183 - POLYMER NITRILE EXAMINATION GLOVES (BLU...

K974183 is an FDA 510(k) clearance for POLYMER NITRILE EXAMINATION GLOVES (BLU..., manufactured by Sri Johani Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K974183 · Sri Johani Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
42d
Days
Class 1
Risk

K974183 is an FDA 510(k) clearance for the POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Sri Johani Sdn. Bhd. (Selangor, MY). The FDA issued a Cleared decision on December 18, 1997 after a review of 42 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 Sri Johani Sdn. Bhd. devices

FDA 510(k) Submission Details - K974183

510(k) Number K974183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1997
Decision Date December 18, 1997
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 682
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K974183.
NITRILE PRE-POWDERED EXAMINATION GLOVES
K974907 · Smart Glove Corp. Sdn Bhd · Mar 1998
POWDERED GREEN NITRILE EXAMINATION GLOVES
K974886 · Sri Johani Sdn. Bhd. · Jan 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES
K974887 · Sri Johani Sdn. Bhd. · Jan 1998
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