Cleared Traditional

K001065 - DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR

K001065 is an FDA 510(k) clearance for DISPOSABLE POWDERED NITRILE EXAM GLOVE, manufactured by Sheen More Ent. Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K001065 · Sheen More Ent. Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
50d
Days
Class 1
Risk

K001065 is an FDA 510(k) clearance for the DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Sheen More Ent. Co., Ltd. (Tou-Liu, Yun-Lin, TW). The FDA issued a Cleared decision on May 23, 2000 after a review of 50 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.

FDA 510(k) Submission Details - K001065

510(k) Number K001065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2000
Decision Date May 23, 2000
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 1181
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K001065.
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR
K001637 · Sheen More Ent. Co., Ltd. · Jun 2000
MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE)
K001549 · Shanghai Poseidon Plastic Products Co., Ltd. · Jun 2000
FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM
K000813 · Allegiance Healthcare Coporation · Jun 2000
NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE
K001128 · Shanghai Poseidon Plastic Products Co., Ltd. · May 2000
DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR
K001155 · Sheen More Ent. Co., Ltd. · May 2000
POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K991422 · Shen Wei (Usa), Inc. · May 2000
K001065 · DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
Download PDF Sheen More Ent. Co., …