Cleared Traditional

K990883 - LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)

K990883 is an FDA 510(k) clearance for LAGLOVE BRAND BLUE COLOLRED NITRILE EXA..., manufactured by La Glove (M) Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K990883 · La Glove (M) Sdn. Bhd. · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 1999
Decision
147d
Days
Class 1
Risk

K990883 is an FDA 510(k) clearance for the LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by La Glove (M) Sdn. Bhd. (Selangor Darul Ehsan Mala, MG). The FDA issued a Cleared decision on August 10, 1999 after a review of 147 days - within the typical 510(k) review window.

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 La Glove (M) Sdn. Bhd. devices

FDA 510(k) Submission Details - K990883

510(k) Number K990883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1999
Decision Date August 10, 1999
Days to Decision 147 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
18d slower than avg
Panel avg: 129d · This submission: 147d
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 952
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K990883.
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE
K992299 · Pamitex Industries Sdn Bhd · Aug 1999
NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)
K991776 · Seltom Pacific Sdn. Bhd. · Aug 1999
NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)
K991779 · Seltom Pacific Sdn. Bhd. · Aug 1999
PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.
K991845 · Omnigrace , Ltd. · Aug 1999
PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE
K991846 · Omnigrace , Ltd. · Aug 1999
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR
K991981 · Alliance Rubber Products Sdn. Bhd. · Aug 1999