FDA.reportPublic FDA data

Nitrile Examination Gloves Powder Free

Primary DI
18994452290050
Brand
Nitrile Examination Gloves Powder Free
Company
PT. SINTONG UNIGOLDEN GLOVE
Model
Large
Device description
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) - (Large)
Published
2024-02-26
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

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223235000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223235000Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)Pt. Sintong Unigolden Glove2022-10-26LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18994452290050PackageGS110In Commercial Distribution
08994452290053PrimaryGS10
08994452290114Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1899445229005018994452290050
08994452290053089944522900538994452290053
08994452290114089944522901148994452290114

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+6281253206449sug.qualityassurance@gmail.com

Regulatory Flags#

DUNS number
565034612
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08994452290022Nitrile Examination Gloves Powder FreeX - Small2024-02-26
08994452290039Nitrile Examination Gloves Powder FreeSmall2024-02-26
08994452290046Nitrile Examination Gloves Powder FreeMedium2024-02-26
08994452290053Nitrile Examination Gloves Powder FreeLarge2024-02-26
08994452290060Nitrile Examination Gloves Powder FreeX - Large2024-02-26
18994452290029Nitrile Examination Gloves Powder FreeX - Small2024-02-26
18994452290036Nitrile Examination Gloves Powder FreeSmall2024-02-26
18994452290043Nitrile Examination Gloves Powder FreeMedium2024-02-26
18994452290067Nitrile Examination Gloves Powder FreeX - Large2024-02-26
08994452290077Nitrile Examination Gloves Powder FreeXX - Large2024-02-23
08994452290138Nitrile Examination Gloves Powder FreeXX - Large2024-02-23

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