Cleared Traditional

K990750 - DERMAGRIP POWDER FREE BLUE NITRILE EXAM...

K990750 is an FDA 510(k) clearance for DERMAGRIP POWDER FREE BLUE NITRILE EXAM..., manufactured by Wrp Specialty Products Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K990750 · Wrp Specialty Products Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
221d
Days
Class 1
Risk

K990750 is an FDA 510(k) clearance for the DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Wrp Specialty Products Sdn. Bhd. (Selangor Daurl Ehsan, Sepang, MY). The FDA issued a Cleared decision on October 15, 1999 after a review of 221 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Wrp Specialty Products Sdn. Bhd. devices

FDA 510(k) Submission Details - K990750

510(k) Number K990750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1999
Decision Date October 15, 1999
Days to Decision 221 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
92d slower than avg
Panel avg: 129d · This submission: 221d
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 749
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K990750.
COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE
K993311 · Wrp Asia Pacific Sdn. Bhd. · Nov 1999
SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE
K992830 · Safeskin Corp. · Oct 1999
DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE
K990752 · Wrp Specialty Products Sdn. Bhd. · Oct 1999
NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K992768 · Ansell Perry · Oct 1999
SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES
K992210 · Safeskin Corp. · Sep 1999
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE
K992223 · Pamitex Industries Sdn Bhd · Aug 1999