Medline Aloe Touch Sterile Nitrile Examination Gloves with Aloe Vera

FDA 510(k) K003353 · Medline Industries, Inc.

Substantially Equivalent

510(k) numberK003353

Submission

Device name
Medline Aloe Touch Sterile Nitrile Examination Gloves with Aloe Vera
Applicant
Medline Industries, Inc.
Mundelein, IL, US
Received
October 26, 2000
Decision date
November 22, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LZA – Polymer Patient Examination Glove
Device class
Class I (low risk)
Regulation
21 CFR 880.6250
Specialty
General Hospital

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.

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K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder…LZA · Special Top Glove Sdn. Bhd.09/09/2026SE
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K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs…LZA · Special Gmp Medicare Sdn. Bhd.09/08/2026SE
K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT…LZA · Traditional Kossan International Sdn Bhd08/18/2026SE
K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile…LZA · Special O&M Halyard, Inc.07/21/2026SE
K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua…LZA · Special Hartalega NGC Sdn. Bhd.07/20/2026SE
K252117Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with…LZA · Special Sw Technologies, Inc.06/24/2026SE
K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackLZA · Traditional Kanglongda Vietnam Protection Technology Company…06/18/2026SE
K260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and…LZA · Special Hartalega NGC Sdn. Bhd.06/17/2026SE
K260806Nitrile Disposable Examination GlovesLZA · Traditional Vista Industries,, LLC06/03/2026SE

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Questions and answers

When was Medline Aloe Touch Sterile Nitrile Examination Gloves with Aloe Vera cleared by the FDA?

Medline Aloe Touch Sterile Nitrile Examination Gloves with Aloe Vera (K003353) received a 510(k) decision of Substantially Equivalent on November 22, 2000, 27 days after the submission was received.

What is the product code of K003353?

The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.