Cleared Traditional

K101630 - POWDER FREE NITRILE EXAMINATION GLOVES ...

K101630 is an FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVES ..., manufactured by Pt. Smartglove Indonesia. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K101630 · Pt. Smartglove Indonesia · General Hospital
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Sep 2010
Decision
89d
Days
Class 1
Risk

K101630 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERA.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Pt. Smartglove Indonesia (Morawa,Deli Serdang,Sumatera U, ID). The FDA issued a Cleared decision on September 7, 2010 after a review of 89 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 Pt. Smartglove Indonesia devices

FDA 510(k) Submission Details - K101630

510(k) Number K101630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2010
Decision Date September 07, 2010
Days to Decision 89 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 129d · This submission: 89d
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 750
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K101630.
NUGARD NITILE GREY COLOR
K102230 · Terang Nusa Sdn Bhd · Sep 2010
NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
K101646 · Sgmp Co., Ltd. · Sep 2010
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
K102032 · Kimberly-Clark Corp. · Sep 2010
LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)
K093335 · La Glove (M) Sdn. Bhd. · Jun 2010
MICRO-TOUCH NITRILE
K093523 · Ansell Healthcare Products, LLC · Mar 2010
MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K093726 · Medline Industries, Inc. · Feb 2010