Shengkun

Primary DI
06975913080118
Brand
Shengkun
Company
Zibo Shengkun Chemical Industry Co., Ltd.
Model
GP_FG03
Device description
Powder Free Polyurethane Examination Gloves , Green, Medium
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06975913080118PrimaryGS10
06975913080132Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06975913080118069759130801186975913080118
06975913080132069759130801326975913080132

GMDN Terms

TermDefinition
Polyurethane examination/treatment glove, non-powderedA device made of polyurethane 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 antimicrobials. 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.

Regulatory Flags

DUNS number
528106527
Device count
100
DM exempt
true
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
true
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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