Cleared Traditional

K992588 - BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE

K992588 is an FDA 510(k) clearance for BLUE NITRILE PATIENT EXAMINATION GLOVES, manufactured by Formosa Glove Industrial Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K992588 · Formosa Glove Industrial Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
39d
Days
Class 1
Risk

K992588 is an FDA 510(k) clearance for the BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Formosa Glove Industrial Co., Ltd. (Westfield, US). The FDA issued a Cleared decision on September 10, 1999 after a review of 39 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 Formosa Glove Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K992588

510(k) Number K992588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1999
Decision Date September 10, 1999
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 975
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K992588.
QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES
K992671 · Latexx Partners Bhd. · Sep 1999
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR
K992686 · Sheen More Ent. Co., Ltd. · Sep 1999
SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES
K992210 · Safeskin Corp. · Sep 1999
N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K992170 · Best Manufacturing Company · Sep 1999
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE
K992223 · Pamitex Industries Sdn Bhd · Aug 1999
SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES
K992062 · Safeskin Corp. · Aug 1999