FDA.reportPublic FDA data

Nulife

Primary DI
08905159001798
Brand
Nulife
Company
MRK HEALTHCARE PRIVATE LIMITED
Model
Latex Surgical Gloves - Size 8.0
Catalog number
SRGLUE
Device description
Latex Surgical gloves are sterile, anatomically shaped medical gloves with the thumb positioned towards the palmer surface of the index finger rather than lying flat. These gloves are powder free. The surgical gloves are intended for use in invasive surgeries.
Published
2023-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210969000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210969000NulifeMrk Healthcare Pvt, Ltd.2021-11-03KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08905159001798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08905159001798089051590017988905159001798

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; 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 both the patient and the staff against contamination from microorganisms. 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+912262611111regulatory@mrkhealthcare.com

Regulatory Flags#

DUNS number
650986016
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08905159002122NulifeElbow length Gynaecology gloves - 6.5ELGLUE2023-06-28
08905159002139NulifeElbow length Gynaecology gloves - 7.5ELGLUE2023-06-28
08905159002146NulifeElbow length Gynaecology gloves - 8.5ELGLUE2023-06-28
08905159002153NulifeUltra Gloves Beadless Size - 5.5ULTLUEBL2023-06-28
08905159002160NulifeUltra Gloves Beadless Size - 6.0ULTLUEBL2023-06-28
08905159002177NulifeUltra Gloves Beadless Size - 6.5ULTLUEBL2023-06-28
08905159002184NulifeUltra Gloves Beadless Size - 7.0ULTLUEBL2023-06-28
08905159002191NulifeUltra Gloves Beadless Size - 7.5ULTLUEBL2023-06-28
08905159002207NulifeUltra Gloves Beadless Size - 8.0ULTLUEBL2023-06-28
08905159002214NulifeUltra Gloves Beadless Size - 8.5ULTLUEBL2023-06-28
08905159002221NulifeUltra Gloves Beadless Size - 9.0ULTLUEBL2023-06-28
08905159001743NulifeLatex Surgical Gloves - Size 5.5SRGLUE2023-06-27
08905159001750NulifeLatex Surgical Gloves - Size 6.0SRGLUE2023-06-27
08905159001767NulifeLatex Surgical Gloves - Size 6.5SRGLUE2023-06-27
08905159001774NulifeLatex Surgical Gloves - Size 7.0SRGLUE2023-06-27
08905159001781NulifeLatex Surgical Gloves - Size 7.5SRGLUE2023-06-27
08905159001804NulifeLatex Surgical Gloves - Size 8.5SRGLUE2023-06-27
08905159001811NulifeLatex Surgical Gloves - Size 9.0SRGLUE2023-06-27

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