Cleared Traditional

K972838 - POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED)

K972838 is an FDA 510(k) clearance for POWDER-FREE NITRILE, manufactured by Absolute Synthetic Technologies Malaysia Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K972838 · Absolute Synthetic Technologies Malaysia Sdn. Bhd. · General Hospital
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Aug 1997
Decision
14d
Days
Class 1
Risk

K972838 is an FDA 510(k) clearance for the POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLO.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Absolute Synthetic Technologies Malaysia Sdn. Bhd. (Kamunting, Taiping, Perak, MY). The FDA issued a Cleared decision on August 15, 1997 after a review of 14 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 Absolute Synthetic Technologies Malaysia Sdn. Bhd. devices

FDA 510(k) Submission Details - K972838

510(k) Number K972838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1997
Decision Date August 15, 1997
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K972838.
NITRILE EXAMINATION GLOVES-PRE POWDERED
K970216 · Influx Pacific Sdn. Bhd. · Sep 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
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K972177 · Absolute Synthetic Technologies Malaysia Sdn. Bhd. · Jul 1997
POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K972195 · Absolute Synthetic Technologies Malaysia Sdn. Bhd. · Jul 1997
SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES
K971666 · Sj Medical Products (M) Sdn Bhd · Jul 1997

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.