FDA.report

sunnycare

Primary DI
00850044355679
Brand
sunnycare
Company
Agio Group Inc.
Model
8204
Device description
sunnycare brand nitrile examination gloves powder free size xlarge 100pcs/box; 10 boxes/case blue color powder free chemo rated
Published
2022-09-29
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
LZAPolymer Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20850044355673PackageGS1100In Commercial Distribution
10850044355676PrimaryGS10
00850044355679Unit of UseGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
2085004435567314208500443556732Indicator 2 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
1085004435567614108500443556761Indicator 1 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
00850044355679140085004435567908500443556790850044355679Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

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

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
true
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
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
20850044355840sunnycare760376032022-09-27

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