Cleared Traditional

K990575 - TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES

K990575 is an FDA 510(k) clearance for TA CHIA POWDERED NON-STERILE NITRILE PA..., manufactured by Ta Chia Rubber Ind. Corp.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K990575 · Ta Chia Rubber Ind. Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
70d
Days
Class 1
Risk

K990575 is an FDA 510(k) clearance for the TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Ta Chia Rubber Ind. Corp. (Ta Chia, Taichung, TW). The FDA issued a Cleared decision on May 4, 1999 after a review of 70 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 Ta Chia Rubber Ind. Corp. devices

FDA 510(k) Submission Details - K990575

510(k) Number K990575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1999
Decision Date May 04, 1999
Days to Decision 70 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
59d faster than avg
Panel avg: 129d · This submission: 70d
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 1027
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K990575.
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE
K990698 · Omnigrace (Thailand) , Ltd. · May 1999
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE
K990701 · Omnigrace (Thailand) , Ltd. · May 1999
SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE
K984249 · London International Group, Inc. · May 1999
TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
K990577 · Ta Chia Rubber Ind. Corp. · May 1999
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE
K990695 · Omnigrace (Thailand) , Ltd. · May 1999
ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE
K990427 · Alliance Rubber Products Sdn. Bhd. · Apr 1999