Medline Sterile Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)

FDA 510(k) K003055 · Medline Industries, Inc.

Substantially Equivalent

510(k) numberK003055

Submission

Device name
Medline Sterile Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)
Applicant
Medline Industries, Inc.
Mundelein, IL, US
Received
October 2, 2000
Decision date
January 26, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

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

A latex patient examination glove is a disposable device made of natural rubber latex 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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K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein…LYY · Traditional Kossan International Sdn Bhd06/13/2023SE
K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)LYY · Traditional Shandong Intco Medical Products Co, Ltd.02/22/2023SE
K222612Powder-Free Latex examination glovesLYY · Traditional Guangdong Kingfa Sci. & Tech.Co., Ltd.11/25/2022SE
K221667Non Sterile Powder Free Latex Examination GloveLYY · Traditional New Era Medicare Sdn. Bhd.10/28/2022SE
K222348JR MedicLYY · Abbreviated Jr Engineering & Medical Technologies (M) Sdn.…10/27/2022SE
K221374Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)LYY · Traditional Hebei Titans Hongsen Medical Technology Co., Ltd.10/26/2022SE
K222693Single-use medical latex examination gloves (LG100)LYY · Traditional Fitone Latex Products Co., Ltd. Guangdong09/24/2022SE
K221648Iconic Latex GloveLYY · Traditional Iconic Medicare Sdn Bhd08/25/2022SE

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Questions and answers

When was Medline Sterile Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) cleared by the FDA?

Medline Sterile Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) (K003055) received a 510(k) decision of Substantially Equivalent on January 26, 2001, 116 days after the submission was received.

What is the product code of K003055?

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