Cleared Traditional

K970216 - NITRILE EXAMINATION GLOVES-PRE POWDERED

K970216 is an FDA 510(k) clearance for NITRILE EXAMINATION GLOVES-PRE POWDERED, manufactured by Influx Pacific Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K970216 · Influx Pacific Sdn. Bhd. · General Hospital
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Sep 1997
Decision
253d
Days
Class 1
Risk

K970216 is an FDA 510(k) clearance for the NITRILE EXAMINATION GLOVES-PRE POWDERED. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Influx Pacific Sdn. Bhd. (Malacca, West Malaysia, MY). The FDA issued a Cleared decision on September 26, 1997 after a review of 253 days - an extended review 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: 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.

View all Influx Pacific Sdn. Bhd. devices

FDA 510(k) Submission Details - K970216

510(k) Number K970216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1997
Decision Date September 26, 1997
Days to Decision 253 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
124d slower than avg
Panel avg: 129d · This submission: 253d
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 K970216.
POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES
K972090 · Shen Wei (Usa), Inc. · Nov 1997
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
POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE
K972306 · P.T. Irama Dinamika Latex · 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