Cleared Traditional

K993313 - COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE

K993313 is an FDA 510(k) clearance for COMFIT POWDER FREE BLUE NITRILE EXAMINA..., 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 50-day FDA review.

K993313 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
50d
Days
Class 1
Risk

K993313 is an FDA 510(k) clearance for the COMFIT POWDER FREE BLUE 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 23, 1999 after a review of 50 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 - K993313

510(k) Number K993313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1999
Decision Date November 23, 1999
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 K993313.
BLUE NITRILE EXAMINATION GLOVES - POWDER FREE
K994064 · Glove Source, Inc. · Jan 2000
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 NITRILE EXAMINATION GLOVE, STERILE
K993311 · 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