FDA.reportPublic FDA data

LYDUS Nitrile Examination Gloves, Powder Free

Primary DI
00711583360954
Brand
LYDUS Nitrile Examination Gloves, Powder Free
Company
The Stronghold Group LLC
Model
FRSNS-LYDUSNTRL
Device description
Patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. See product packaging for size identification. Carton of 100 pieces/inner box.
Published
2022-02-27
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

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
K203191000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203191000LYDUS Nitrile Examination Gloves, Powder FreeNathan Trading Co., Ltd.2021-02-12LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00711583360954PackageGS110In Commercial Distribution
00711583361104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00711583360954007115833609547115833609540711583360954
00711583361104007115833611047115833611040711583361104

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit100 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080344373
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850037694648Stronghold PP/PE Isolation Gown (AAMI Level 2)-SSC200S2022-03-19
00850037694655Stronghold PP/PE Isolation Gown (AAMI Level 2)-MSC200M2022-03-19
00850037694662Stronghold PP/PE Isolation Gown (AAMI Level 2)-LSC200L2022-03-19
00850037694679Stronghold PP/PE Isolation Gown (AAMI Level 2)-XLSC200XL2022-03-19
00850037694686Stronghold PP/PE Isolation Gown (AAMI Level 2)-UnisizeSC200U2022-03-19
00850037694730Stronghold SMS Isolation Gown (AAMI Level 2)-SSC210S2022-03-19
00850037694747Stronghold SMS Isolation Gown (AAMI Level 2)-MSC210M2022-03-19
00850037694754Stronghold SMS Isolation Gown (AAMI Level 2)-LSC210L2022-03-19
00850037694761Stronghold SMS Isolation Gown (AAMI Level 2)-XLSC210XL2022-03-19
00850037694778Stronghold SMS Isolation Gown (AAMI Level 2)-UnisizeSC210U2022-03-19
10850037694645Stronghold PP/PE Isolation Gown (AAMI Level 2)-SSC200S2022-03-19
00850037694693Stronghold PP/PE Isolation Gown (AAMI Level 2)-MSC200M2022-03-19
00850037694709Stronghold PP/PE Isolation Gown (AAMI Level 2)-LSC200L2022-03-19
00850037694716Stronghold PP/PE Isolation Gown (AAMI Level 2)-XLSC200XL2022-03-19
00850037694723Stronghold PP/PE Isolation Gown (AAMI Level 2)-UnisizeSC200U2022-03-19
00850037694785Stronghold SMS Isolation Gown (AAMI Level 2)-SSC210S2022-03-19
00850037694792Stronghold SMS Isolation Gown (AAMI Level 2)-MSC210M2022-03-19
00850037694808Stronghold SMS Isolation Gown (AAMI Level 2)-LSC210L2022-03-19
00850037694815Stronghold SMS Isolation Gown (AAMI Level 2)-XLSC210XL2022-03-19
00850037694822Stronghold SMS Isolation Gown (AAMI Level 2)-UnisizeSC210U2022-03-19

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