What is FDA product code LYY?

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.

General Hospital › MiscellaneousLatex Patient Examination Glove

Zhanjiang Jiali

Name: Zhanjiang Jiali
Brand: Zhanjiang Jiali

Catalogue number Polymer patient examination glove, L, Po, listed by Zhanjiang Jiali Glove Products Co., Ltd., China, under Latex Patient Examination Glove. 12 manufacturers in China are registered for this product code.

Registry build 21.09.26

12manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Shandong (6), Guangdong (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LYY
Manufacturer	City	Province	Registered as	Device types
Zhangjiagang Dayu Rubber Products Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	4
Guangzhou Noval Medical Co., Ltd.	Guangzhou	Guangdong	Manufacturer	9
Shandong Intco Medical Products Co Ltd	Qingzhou	Shandong	Contract manufacturer	6
Alcatron Gloves Factory	Weifang	Shandong	Specification developer	6
Shanghai Motex Healthcare Co., Ltd.	Shanghai	Shanghai	Manufacturer	4
True Glove Factory	Weifang	Shandong	Specification developer	4
Motex Healthcare (Anhui) Co., Ltd.	Guangde City, Xuancheng	Anhui	Manufacturer	4
Novapro Co., Ltd.	Zibo	Shandong	Specification developer	3
Shandong Huayue Glove Co., Ltd.	Zibo	Shandong	Manufacturer	3
Huizhou Anboson Technology Co., Ltd.	Huizhou	Guangdong	Manufacturer	3
Shanghai Jinxiang Latex Products Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	3
Zibo Blue Sail Health Technology Co., Ltd.	Zibo	Shandong	Specification developer	3

Record

Regulatory record for Zhanjiang Jiali
Listed by	Zhanjiang Jiali Glove Products Co., Ltd., China
FDA product code	LYY
Device type	Latex Patient Examination Glove
Device class	Class 1
Regulation	21 CFR 880.6250
510(k)	K072145
Record published	2023-10-09

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Zhanjiang Jiali
Catalogue number	Size	Status
Polymer patient examination glove, L, Powder-free, Blue		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Microflex	Ansell Healthcare Product	56
Henry Schein	Henry Schein, Inc.	36
BioSkin	Liberty Glove & Safety, LLC	30
McKesson	Mckesson Medical-Surgical Inc.	28
Hopkins Medical Products®	Hopkins Uniform Company	26
Blossom	Mexpo International, Inc.	25
Cranberry	Ascend Eagle, Inc.	24
Darby Dental Supply, LLC	Darby Dental Supply, LLC	23
Tronex International, Inc.	Tronex International, Inc.	20
Ammex Professional	Ammex Corporation	20
AmbiCanner	Summit Glove, Inc.	20
Micro-Touch	Ansell Healthcare Product	17

Showing 12 of 316. All products under Latex Patient Examination Glove

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K072145	2008-02-26

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.