Cleared Traditional

K101595 - POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE

K101595 is an FDA 510(k) clearance for POWDER FREE NITRILE PATIENT EXAMINATION..., manufactured by Better Care Plastic Technology Cp., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K101595 · Better Care Plastic Technology Cp., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
59d
Days
Class 1
Risk

K101595 is an FDA 510(k) clearance for the POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Better Care Plastic Technology Cp., Ltd. (Chino, US). The FDA issued a Cleared decision on August 6, 2010 after a review of 59 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 - K101595

510(k) Number K101595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2010
Decision Date August 06, 2010
Days to Decision 59 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
70d faster than avg
Panel avg: 129d · This submission: 59d
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 1177
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K101595.
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
K102032 · Kimberly-Clark Corp. · Sep 2010
POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE
K101630 · Pt. Smartglove Indonesia · Sep 2010
NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
K100975 · Jiangsu Sunshine Plastic Products, Co., Ltd. · Aug 2010
RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
K100603 · Riverstone Resources Sdn Bhd · Jul 2010
NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE
K100979 · Jiangsu Sunshine Plastic Products, Co., Ltd. · Jul 2010
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
K101293 · Pt. Smartglove Indonesia · Jul 2010
K101595 · POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
Download PDF FDA Summary Better Care Plastic T…