Cleared Traditional

K972306 - POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE

K972306 is an FDA 510(k) clearance for POWDERFREE COLORED AND FLAVORED NITRILE..., manufactured by P.T. Irama Dinamika Latex. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K972306 · P.T. Irama Dinamika Latex · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
85d
Days
Class 1
Risk

K972306 is an FDA 510(k) clearance for the POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by P.T. Irama Dinamika Latex (Indonesia, ID). The FDA issued a Cleared decision on September 12, 1997 after a review of 85 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 P.T. Irama Dinamika Latex devices

FDA 510(k) Submission Details - K972306

510(k) Number K972306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1997
Decision Date September 12, 1997
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 777
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K972306.
ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE
K972757 · Shield Gloves Manufacturer (M) Sdn Bhd · Oct 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K972169 · Pwa Industries Sdn. Bhd. · Oct 1997
NITRILE EXAMINATION GLOVES-PRE POWDERED
K970216 · Influx Pacific Sdn. Bhd. · Sep 1997
POWDER FREE SYNTHETIC EXAMINATION GLOVES
K971356 · Arista Latindo Industrial Ltd. P.T · Sep 1997
POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED)
K972838 · Absolute Synthetic Technologies Malaysia Sdn. Bhd. · Aug 1997
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K972177 · Absolute Synthetic Technologies Malaysia Sdn. Bhd. · Jul 1997