FDA.reportPublic FDA data

DEFENDER PLUS

Primary DI
00850031575226
Brand
DEFENDER PLUS
Company
Armstrong Medical Supply, LLC
Model
AMSDEF5-XL
Device description
Nitrile disposable 5 mil powder-free examination glove, 100 gloves per box. Medical Grade, Chemotherapy drug tested, Not made with Rubber Latex, Low Derma, Protection against Fentanyl, Single use, Non-sterile. Size is X-large.
Published
2021-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

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
K181857000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181857000Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl CitrateKossan International Sdn Bhd2018-11-20LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850031575226PackageGS110In Commercial Distribution
00850031575165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850031575226008500315752268500315752260850031575226
00850031575165008500315751658500315751650850031575165

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 Humidity65 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2819709411tcarter@armstrongmed.com

Regulatory Flags#

DUNS number
962708454
Device count
1
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
false
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
00850031575127DEFENDER PLUSAMSDEF5-XS2021-06-04
00850031575134DEFENDER PLUSAMSDEF5-S2021-06-04
00850031575141DEFENDER PLUSAMSDEF5-M2021-06-04
00850031575158DEFENDER PLUSAMSDEF5-L2021-06-04
00850031575165DEFENDER PLUSAMSDEF5-XL2021-06-04
00850031575172DEFENDER PLUSAMSDEF5-XXL2021-06-04
00850031575240DEFENDER MAXAMSDEF6-XS2021-06-14
00850031575257DEFENDER MAXAMSDEF6-S2021-06-14
00850031575264DEFENDER MAXAMSDEF6-M2021-06-14
00850031575271DEFENDER MAXAMSDEF6-L2021-06-14
00850031575288DEFENDER MAXAMSDEF6-XL2021-06-14
00850031575295DEFENDER MAXAMSDEF6-XXL2021-06-14
00850031575301DEFENDER MAXAMSDEF6-XS2021-06-14
00850031575318DEFENDER MAXAMSDEF6-S2021-06-14
00850031575325DEFENDER MAXAMSDEF6-M2021-06-14
00850031575332DEFENDER MAXAMSDEF6-L2021-06-14
00850031575349DEFENDER MAXAMSDEF6-XL2021-06-14
00850031575356DEFENDER MAXAMSDEF6-XXL2021-06-14
00850031575189DEFENDER PLUSAMSDEF5-XS2021-06-04
00850031575196DEFENDER PLUSAMSDEF5-S2021-06-04

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Primary DI, Brand, Company table
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05060264110056Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110070Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
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