Cleared Traditional

K993134 - CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN)

K993134 is an FDA 510(k) clearance for CASHMERE NON-STERILE BLUE POWDERED NITR..., manufactured by Seal Polymer Industries Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K993134 · Seal Polymer Industries Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
58d
Days
Class 1
Risk

K993134 is an FDA 510(k) clearance for the CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Seal Polymer Industries Bhd. (Lahat, Ipoh, Perak, MY). The FDA issued a Cleared decision on November 17, 1999 after a review of 58 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 Seal Polymer Industries Bhd. devices

FDA 510(k) Submission Details - K993134

510(k) Number K993134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1999
Decision Date November 17, 1999
Days to Decision 58 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
71d faster than avg
Panel avg: 129d · This submission: 58d
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 862
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K993134.
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
CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN
K993133 · Seal Polymer Industries Bhd. · Nov 1999
OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
K993050 · Omnigrace , Ltd. · Nov 1999
QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED
K992924 · Latexx Partners Bhd. · Nov 1999
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K993247 · Jda Intl., Inc. · Nov 1999