FDA.report

Hongray

Primary DI
06974831910187
Brand
Hongray
Company
Luliang Hongruida Health Protection Technology Co., Ltd.
Model
XXL
Device description
Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, 2X-Large – 1000/case
Published
2024-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06974831910064PrimaryGS10
06974831910125PrimaryGS10
06974831910187Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06974831910064069748319100646974831910064
06974831910125069748319101256974831910125
06974831910187069748319101876974831910187

GMDN Terms

TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+8631166179668hongrayline3@hongray.com.cn

Regulatory Flags

DUNS number
602679965
Device count
1000
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06974831910132HongrayXS2024-03-14
06974831910149HongrayS2024-03-14
06974831910156HongrayM2024-03-14
06974831910163HongrayL2024-03-14
06974831910170HongrayXL2024-03-14

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