Cleared Traditional

K000813 - FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM

K000813 is an FDA 510(k) clearance for FLEXAM NITRILE T AMBI EXAMINATION GLOVE..., manufactured by Allegiance Healthcare Coporation. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K000813 · Allegiance Healthcare Coporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
87d
Days
Class 1
Risk

K000813 is an FDA 510(k) clearance for the FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Allegiance Healthcare Coporation (Mcgaw Park, US). The FDA issued a Cleared decision on June 8, 2000 after a review of 87 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 Allegiance Healthcare Coporation devices

FDA 510(k) Submission Details - K000813

510(k) Number K000813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2000
Decision Date June 08, 2000
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 129d · This submission: 87d
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 1169
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K000813.
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE
K001837 · Shanghai Poseidon Plastic Products Co., Ltd. · Jul 2000
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR
K001637 · Sheen More Ent. Co., Ltd. · Jun 2000
MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE)
K001549 · Shanghai Poseidon Plastic Products Co., Ltd. · Jun 2000
DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
K001065 · Sheen More Ent. Co., Ltd. · May 2000
NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE
K001128 · Shanghai Poseidon Plastic Products Co., Ltd. · May 2000
DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR
K001155 · Sheen More Ent. Co., Ltd. · May 2000