Cleared Traditional

K981878 - POWDERFREE NITRILE EXAMINATION GLOVES (...

K981878 is an FDA 510(k) clearance for POWDERFREE NITRILE EXAMINATION GLOVES (..., manufactured by Besglove Medicare Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K981878 · Besglove Medicare Sdn. Bhd. · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 1998
Decision
75d
Days
Class 1
Risk

K981878 is an FDA 510(k) clearance for the POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Besglove Medicare Sdn. Bhd. (Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on August 11, 1998 after a review of 75 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 Besglove Medicare Sdn. Bhd. devices

FDA 510(k) Submission Details - K981878

510(k) Number K981878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1998
Decision Date August 11, 1998
Days to Decision 75 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
54d faster than avg
Panel avg: 129d · This submission: 75d
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 701
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K981878.
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE
K983729 · Perusahaan Getah Asas Sdn. Bhd. · Dec 1998
NITRILE PATIENT EXAMINATION GLOVE
K982440 · Perusahaan Getah Asas Sdn. Bhd. · Sep 1998
NITRILE POWDERFREE EXAMINATION GLOVES
K981877 · Besglove Medicare Sdn. Bhd. · Aug 1998
POWDERED NITRILE EXAMINATION GLOVES
K981879 · Besglove Medicare Sdn. Bhd. · Aug 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES
K981673 · Besglove Medicare Sdn. Bhd. · Jul 1998
POWDERED GREEN NITRILE EXAMINATION GLOVES
K981674 · Besglove Medicare Sdn. Bhd. · Jul 1998