Cleared Traditional

K993876 - POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA

K993876 is an FDA 510(k) clearance for POWDER-FREE NITRILE EXAMINATION GLOVES ..., manufactured by Shen Wei (Usa), Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K993876 · Shen Wei (Usa), Inc. · General Hospital
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Feb 2000
Decision
84d
Days
Class 1
Risk

K993876 is an FDA 510(k) clearance for the POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shen Wei (Usa), Inc. (Union City, US). The FDA issued a Cleared decision on February 7, 2000 after a review of 84 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 Shen Wei (Usa), Inc. devices

FDA 510(k) Submission Details - K993876

510(k) Number K993876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1999
Decision Date February 07, 2000
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 129d · This submission: 84d
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 1019
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K993876.
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE
K000329 · Siam Sempermed Corp., Ltd. · Apr 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE
K000330 · Siam Sempermed Corp., Ltd. · Apr 2000
NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED)
K993805 · Best Manufacturing Company · Mar 2000
OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
K994246 · Omnigrace , Ltd. · Jan 2000
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