Cleared Traditional

K000688 - UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES

K000688 is an FDA 510(k) clearance for UNIGLOVE NITRILE POWDERED EXAMINATION G..., manufactured by N.S. Uni-Gloves Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K000688 · N.S. Uni-Gloves Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
43d
Days
Class 1
Risk

K000688 is an FDA 510(k) clearance for the UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by N.S. Uni-Gloves Sdn. Bhd. (Torrance, US). The FDA issued a Cleared decision on April 12, 2000 after a review of 43 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 N.S. Uni-Gloves Sdn. Bhd. devices

FDA 510(k) Submission Details - K000688

510(k) Number K000688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2000
Decision Date April 12, 2000
Days to Decision 43 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
86d faster than avg
Panel avg: 129d · This submission: 43d
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 920
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K000688.
NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES
K994124 · Mapa Professional · Aug 2000
POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K991422 · Shen Wei (Usa), Inc. · May 2000
NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES
K000868 · Sgmp Co., Ltd. · Apr 2000
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE
K000323 · Siam Sempermed Corp., Ltd. · Apr 2000
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE
K000329 · Siam Sempermed Corp., Ltd. · Apr 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE
K000330 · Siam Sempermed Corp., Ltd. · Apr 2000