Cleared Traditional

K980807 - NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LARGE)

K980807 is an FDA 510(k) clearance for NITRILE EXAMNATION GLOVES- POWDERFREE (..., manufactured by Pt. Eka Wira Asia. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K980807 · Pt. Eka Wira Asia · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
36d
Days
Class 1
Risk

K980807 is an FDA 510(k) clearance for the NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LARGE). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Pt. Eka Wira Asia (Santa Fe Springs, US). The FDA issued a Cleared decision on April 2, 1998 after a review of 36 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 Pt. Eka Wira Asia devices

FDA 510(k) Submission Details - K980807

510(k) Number K980807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1998
Decision Date April 02, 1998
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
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 808
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K980807.
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)
K981039 · Sri Johani Sdn. Bhd. · Apr 1998
AR SAFE NITRILE EXAMINATION GLOVES
K980589 · Alliance Rubber Products Sdn. Bhd. · Apr 1998
NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE)
K980729 · Pt. Eka Wira Asia · Apr 1998
NITRILE EXAM GLOVE, POWDER-FREE, BLUE
K980802 · Tucker & Associates · Mar 1998
NITRILE EXAM GLOVE, POWDER FREE
K980677 · Ningbo Yujiang Plastic & Rubber Co. , Ltd. · Mar 1998
NITRILE PRE-POWDERED EXAMINATION GLOVES
K974907 · Smart Glove Corp. Sdn Bhd · Mar 1998