Vinyl Patient Examination Glove

Device Code: 2664

Product Code(s): LYZ

Definition: A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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 Inf

Device Classification Information

• Device Type ID: 2664
• Device Name: Vinyl Patient Examination Glove
• Regulation Description: Non-powdered Patient Examination Glove.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Infection Control Devices Branch (INCB)
• Submission Type: 510(k)
• CFR Regulation Number: 880.6250 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: LYZ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 5-62 ANSI ASQ Z1.4-2008 (R2013)
  Sampling Procedures And Tables For Inspection By Attributes
• 6-145 ASTM D3578-05 (Reapproved 2015)
  Standard Specification For Rubber Examination Gloves
• 6-147 ASTM D6978-05 (Reapproved 2013)
  Standard Practice For Assessment Of Resistance Of Medical Gloves To Permeation By Chemotherapy Drugs
• 6-175 ASTM D5151-06 (Reapproved 2015)
  Standard Test Method For Detection Of Holes In Medical Gloves
• 6-176 ASTM D7103-06 (Reapproved 2013)
  Standard Guide For Assessment Of Medical Gloves
• 6-178 ASTM D6124-06 (Reapproved 2017)
  Standard Test Method For Residual Powder On Medical Gloves
• 6-183 ASTM D5250-06 (Reapproved 2015)
  Standard Specification For Poly(vinyl Chloride) Gloves For Medical Application
• 6-354 ASTM D7907-14
  Standard Test Methods For Determination Of Bactericidal Efficacy On The Surface Of Medical Examination Gloves
• 6-401 ASTM D7160-16
  Standard Practice For Determination Of Expiration Dating For Medical Gloves

Total Product Life Cycle

• Device Type ID: 2664
• Device: Vinyl Patient Examination Glove
• Product Code: LYZ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Non-powdered Patient Examination Glove.
• CFR Regulation Number: 880.6250 [🔎]

Premarket Reviews
Manufacturer	Decision
AIDE PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
AIR PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BENTENG PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CABIN PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
DAHOON PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DAXWELL, LLC
	SUBSTANTIALLY EQUIVALENT	1
DECENT PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
FEIYUE GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FRIEND PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GRAND
	SUBSTANTIALLY EQUIVALENT	1
GRAND WORK PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEZE CITY GREEN FOOD CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOPE PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INPRO TECHNOLOGY DEVICE FACTORY
	SUBSTANTIALLY EQUIVALENT	1
JEWEL PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIAWANG GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KAIXUAN PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MADE PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG BINXIANG MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG DAWEI MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HAOYU MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG YIFAN PLASTIC PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANXI HONGJIN PLASTIC TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
SHIJIAZHUANG AOK PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHIJIAZHUANG RICHFUL PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHIJIAZHUANG WALLY PLASTICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHIJIAZHUANG WINFUL PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHIJIAZHUNAG JIUYUAN PLASTIC CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHU TONG XINGHUA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHUNTONG GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUPERMAX PLASTIC PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XINGYUAN PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YONGFA GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YONGHE PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHAOFENG GLOVE CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZIBO
	SUBSTANTIALLY EQUIVALENT	2
ZIBO CHANGDA PLASTIC PRODUCTS COMPANY, LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ZIBO DAIYANG PLASTIC COMPANY
	SUBSTANTIALLY EQUIVALENT	1
ZIBO HUAQI TRADING CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZIBO HUIYING MEDICAL PRODUCTS, CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZIBO INTCO MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZIBO SANYING TRADE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZIBO YUSHENG PLASTIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZIBO ZHOUHENG PLASTIC PRODUCTS CO. LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Contamination During Use	1
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	2

Recalls
Manufacturer		Recall Class	Date Posted
1	CYPRESS MEDICAL PRODUCTS	II	Dec-12-2016
2	Cypress Medical Products LLC	II	Aug-16-2018

TPLC Last Update: 2019-04-02 20:16:57