Cleared Traditional

K001375 - ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)

K001375 is an FDA 510(k) clearance for ULTIMATE N-DEX POWER FREE NITRILE EXMIN..., manufactured by Best Manufacturing Company. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K001375 · Best Manufacturing Company · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
85d
Days
Class 1
Risk

K001375 is an FDA 510(k) clearance for the ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMO.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Best Manufacturing Company (Menlo, US). The FDA issued a Cleared decision on July 25, 2000 after a review of 85 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.

FDA 510(k) Submission Details - K001375

510(k) Number K001375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2000
Decision Date July 25, 2000
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
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 1181
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K001375.
MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)
K001497 · Multisafe Sdn. Bhd. · Jul 2000
MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)
K001619 · Multisafe Sdn. Bhd. · Jul 2000
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE
K001836 · Shanghai Poseidon Plastic Products Co., Ltd. · Jul 2000
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
K001375 · ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
Download PDF FDA Summary Best Manufacturing Co…