FDA.report

sunnycare

Primary DI
20850044355840
Brand
sunnycare
Company
Agio Group Inc.
Model
7603
Catalog number
7603
Device description
SUNNYCARE brand vinyl examination gloves powder free clear 100pcs/box, 10boxes/case large size
Published
2022-09-27
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

Product Codes

CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20850044355840PackageGS110In Commercial Distribution
10850044355843PrimaryGS10
00850044355846Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2085004435584020850044355840
1085004435584310850044355843
00850044355846008500443558468500443558460850044355846

GMDN Terms

TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile 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 not covered with talcum powder and it does not have antimicrobial features. 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

Regulatory Flags

DUNS number
611739033
Device count
100
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850044355679sunnycare82042022-09-29
20850044355697sunnycare820182012022-09-29
00850044355709sunnycare820082002022-09-29
20850044355710sunnycare860086002022-09-29
00850044355655sunnycare820282022022-09-28
10850044355683sunnycare820382032022-09-28
20850044355734sunnycare860286022022-09-28
20850044355741sunnycare860386032022-09-28
20850044355758sunnycare860486042022-09-28
20850044355765sunnycare860586052022-09-28
20850044355772sunnycare890189012022-09-28
20850044355789sunnycare890289022022-09-28
20850044355796sunnycare890389032022-09-28
20850044355802sunnycare890489042022-09-28
00850044355815sunnycare890589052022-09-28
20850044355826sunnycare760176012022-09-28
20850044355857sunnycare760476042022-09-28
20850044355727sunnycare860186012022-09-27
20850044355833sunnycare760276022022-09-27

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