Disposable Gloves Size L

Primary DI
04007418924528
Brand
Disposable Gloves Size L
Company
Hans Hepp GmbH & Co. KG
Model
92402
Device description
A device made of vinyl 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 covered with powder to facilitate donning/removal; 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.
Published
2023-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170575000Disposable Powder Free Vinyl Exam Glove, Clear/YellowEver Global (Vietnam) Enterprise Corp2017-05-16LYZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04007418924023PrimaryGS10
04007418924528Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04007418924023040074189240234007418924023
04007418924528040074189245284007418924528

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, powderedA device made of vinyl 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 covered with powder to facilitate donning/removal; 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315896217
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04007418924016Disposable Gloves Size L924012023-08-11
04007418924023Disposable Gloves Size L924022023-08-11
04007418924511Disposable Gloves Size L924012023-08-11
04007418891141Medical Face Mask891142023-07-28
04007418891158Medical Face Mask891152023-07-28
04007418914857Plaster Assortment914852023-07-25
04007418920704Wound Compresses 100mm x 100mm920702023-07-25
04007418920735Wound Compresses 100mm x 100mm920732023-07-25
04007418921404Triangular Bandage 96cm x 96cm x 136cm921402023-07-25
04007418921459Triangular Bandage 96cm x 96cm x 136cm921452023-07-25
04007418921732Elastic Bandage 6cm x 4m921732023-07-25
04007418921831Elastic Bandage 8cm x 4m921832023-07-25
04007418922005First Aid Dressing G Compress 10cm x 12cm922002023-07-25
04007418922036First Aid Dressing G Compress 10cm x 12cm922032023-07-25
04007418922104First Aid Dressing M Compress 8cm x 10cm922102023-07-25
04007418922203First Aid Dressing K Compress 6cm x 8cm922202023-07-25
04007418922234First Aid Dressing K Compress 6cm x 8cm922232023-07-25
04007418922531Bandaging Cloth A 600mm x 800mm922532023-07-25
04007418922555Bandaging Cloth A 600mm x 800mm922552023-07-25
04007418932806Adhesive Tape 5m x 2,5cm932802023-07-25

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