Cleared Traditional

K000330 - NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE

K000330 is an FDA 510(k) clearance for NITRILE PATIENT EXAMINATION GLOVE (GREE..., manufactured by Siam Sempermed Corp., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K000330 · Siam Sempermed Corp., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
63d
Days
Class 1
Risk

K000330 is an FDA 510(k) clearance for the NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Siam Sempermed Corp., Ltd. (Palm Harbor, US). The FDA issued a Cleared decision on April 5, 2000 after a review of 63 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 Siam Sempermed Corp., Ltd. devices

FDA 510(k) Submission Details - K000330

510(k) Number K000330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2000
Decision Date April 05, 2000
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
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 761
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K000330.
NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES
K000868 · Sgmp Co., Ltd. · Apr 2000
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE
K000323 · Siam Sempermed Corp., Ltd. · Apr 2000
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE
K000329 · Siam Sempermed Corp., Ltd. · Apr 2000
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K993876 · Shen Wei (Usa), Inc. · Feb 2000
COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE
K993313 · Wrp Asia Pacific Sdn. Bhd. · Nov 1999
COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE
K993311 · Wrp Asia Pacific Sdn. Bhd. · Nov 1999