Cleared Traditional

K993348 - NIL, NITRILE EXAMINATION GLOVE - POWDER FREE

K993348 is an FDA 510(k) clearance for NIL, manufactured by Sri Anusham Rubber Industries Pvt., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K993348 · Sri Anusham Rubber Industries Pvt., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
45d
Days
Class 1
Risk

K993348 is an FDA 510(k) clearance for the NIL, NITRILE EXAMINATION GLOVE - POWDER FREE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Sri Anusham Rubber Industries Pvt., Ltd. (Vadasery, Nagercoil, Tn, IN). The FDA issued a Cleared decision on November 19, 1999 after a review of 45 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 Sri Anusham Rubber Industries Pvt., Ltd. devices

FDA 510(k) Submission Details - K993348

510(k) Number K993348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1999
Decision Date November 19, 1999
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
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 807
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K993348.
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA
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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
DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE
K990750 · Wrp Specialty Products Sdn. Bhd. · Oct 1999