Cleared Traditional

POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE (K101102) - FDA 510(k) Clearance

Class I General Hospital device.

K101102 · Best Putra Gloves Sdn Bhd · General Hospital
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Jul 2010
Decision
87d
Days
Class 1
Risk

K101102 is an FDA 510(k) clearance for the POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Best Putra Gloves Sdn Bhd (Sg Choh Rawang, Selangor, MY). The FDA issued a Cleared decision on July 16, 2010 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - 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 Best Putra Gloves Sdn Bhd devices

Submission Details

510(k) Number K101102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2010
Decision Date July 16, 2010
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, 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 - KGO Surgeon's Gloves

All 558
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K101102.
Sterile Latex Powder Free Surgical Gloves
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K240790 · Suzhou Colour-Way New Material Co., Ltd. · Aug 2024
Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green)
K232079 · Wrp Asia Pacific Sdn. Bhd. · Mar 2024
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
K232444 · Grand Work Plastic Products Co., Ltd. · Dec 2023
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K231902 · Ansell Healthcare · Oct 2023