Cleared Traditional

K993311 - COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE

K993311 is an FDA 510(k) clearance for COMFIT POWDER FREE NITRILE EXAMINATION ..., manufactured by Wrp Asia Pacific Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K993311 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
46d
Days
Class 1
Risk

K993311 is an FDA 510(k) clearance for the COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Wrp Asia Pacific Sdn. Bhd. (Salak Tinggi, Sepang Selangor, MY). The FDA issued a Cleared decision on November 19, 1999 after a review of 46 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 Wrp Asia Pacific Sdn. Bhd. devices

FDA 510(k) Submission Details - K993311

510(k) Number K993311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1999
Decision Date November 19, 1999
Days to Decision 46 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
83d faster than avg
Panel avg: 129d · This submission: 46d
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 1013
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K993311.
PATIENT NITRILE EXAMINATION GLOVES (POWDERED)
K992675 · Wear Safe Malaysia Sdn. Bhd. · Jan 2000
MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE)
K993127 · Glovesworld Industries Sdn. Bhd. · Dec 1999
COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE
K993313 · Wrp Asia Pacific Sdn. Bhd. · Nov 1999
NIL, NITRILE EXAMINATION GLOVE - POWDERED
K993347 · Sri Anusham Rubber Industries Pvt., Ltd. · Nov 1999
NIL, NITRILE EXAMINATION GLOVE - POWDER FREE
K993348 · Sri Anusham Rubber Industries Pvt., Ltd. · Nov 1999
PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED
K992678 · Wear Safe Malaysia Sdn. Bhd. · Nov 1999