Polymer Patient Examination Glove

Device Code: 2665

Product Code(s): LZA

Definition: 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

Device Classification Information

• Device Type ID: 2665
• Device Name: Polymer 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: LZA
• 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
• 6-165 ASTM D6977-04 (Reapproved 2016)
  Standard Specification For Polychloroprene Examination Gloves For Medical Application
• 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
• 6-244 ASTM D6319-10 (Reapproved 2015)
  Standard Specification For Nitrile Examination Gloves For Medical Application
• 6-338 ASTM D7866-14
  Standard Specification For Radiation Attenuating Protective Gloves
• 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: 2665
• Device: Polymer Patient Examination Glove
• Product Code: LZA
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Non-powdered Patient Examination Glove.
• CFR Regulation Number: 880.6250 [🔎]

Premarket Reviews
Manufacturer	Decision
ADVANCED HEALTH PRODUCTS, LOT 60 & 61
	SUBSTANTIALLY EQUIVALENT	1
ANSELL HEALTHCARE PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1
BETTER CARE PLASTIC TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BRIGHTWAY HOLDINGS SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
CAREPLUS (M) SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
CENTRAL MEDICARE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
ECO MEDI GLOVE SDN BHD
	SUBSTANTIALLY EQUIVALENT	3
ECO MEDI GLOVE SDN. BHD
	SUBSTANTIALLY EQUIVALENT	4
GALLANT QUALITY SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
HALYARD HEALTH
	SUBSTANTIALLY EQUIVALENT	2
HARTALEGA NGC SDN BHD
	SUBSTANTIALLY EQUIVALENT	3
HARTALEGA NGC SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	8
HARTALEGA SDN BHD
	SUBSTANTIALLY EQUIVALENT	8
HARTALEGA SND. BHD.
	SUBSTANTIALLY EQUIVALENT	1
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD
	SUBSTANTIALLY EQUIVALENT	1
HL RUBBER INDUSTRIES SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
HUIKANG GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE, INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERCATOR MEDICAL (THAILAND) LTD.
	SUBSTANTIALLY EQUIVALENT	1
NAM VIET GLOVE JOINT STOCK COMPANY
	SUBSTANTIALLY EQUIVALENT	1
PROFESSIONAL LATEX SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
PT. MAJA AGUNG LATEXINDO
	SUBSTANTIALLY EQUIVALENT	1
PT. MEDISAFE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
PT. SMART GLOVE INDONESIA
	SUBSTANTIALLY EQUIVALENT	1
QUBE MEDICAL PRODUCT SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
RIVERSTONE RESOURCES SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
RIVERSTONE RESOURCES SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
SANREA HEALTHCARE PRODUCTS PVT LTD
	SUBSTANTIALLY EQUIVALENT	1
SEMPERIT INVESTMENTS ASIA PTE LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG XINSHI MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG YUANHANG MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHEN WEI (USA), INC.
	SUBSTANTIALLY EQUIVALENT	1
SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHOWA BEST GLOVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIAM SEMPERMED CORP., LTD
	SUBSTANTIALLY EQUIVALENT	1
SYNTEX HEALTHCARE PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TERANG NUSA SDN BHD
	SUBSTANTIALLY EQUIVALENT	2
TOP CALIBRE SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
TOP GLOVE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
TOP QUALITY GLOVE SDN. BHD
	SUBSTANTIALLY EQUIVALENT	1
VRG KHAI HOAN JOINT STOCK COMPANY
	SUBSTANTIALLY EQUIVALENT	1
WANGHUI GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WRP ASIA PACIFIC
	SUBSTANTIALLY EQUIVALENT	2
WRP ASIA PACIFIC SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	2
WRP RUBBER PRODUCTS SDN BHD
	SUBSTANTIALLY EQUIVALENT	1
YONGXIN HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YTY INDUSTRY
	SUBSTANTIALLY EQUIVALENT	4
YTY INDUSTRY (MANJUNG) SDN BHD
	SUBSTANTIALLY EQUIVALENT	4
ZHIDA GLOVE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZIBO CHENGXUN AUTOMATIC DEVICE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Adverse Event Without Identified Device Or Use Problem	7
Total Device Problems	7

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health	II	Oct-16-2015
2	Halyard Health	II	Dec-14-2016

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