Anthem

Primary DI
00850069531300
Brand
Anthem
Company
Maxter Healthcare Incorporated
Model
17760
Device description
Powder-Free Nitrile Examination Gloves, Non-Sterile, Single Use, Ambidextrous, Disposable Medical Examination Gloves tested for use with chemotherapy drugs in accordance with ASTM D6978.
Published
2026-06-28
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

Product Codes#

Code, Name table
CodeName
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151390000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151390000Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy DrugsMaxter Glove Manufacturing Sdn Bhd2016-05-02LZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850069531300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850069531300008500695313008500695313000850069531300

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.

Regulatory Flags#

DUNS number
119369456
Device count
1
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
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
00850069531256Anthem177652026-06-28
00850069531263Anthem177662026-06-28
00850069531270Anthem177672026-06-28
00850069531287Anthem177682026-06-28
00850069531294Anthem177692026-06-28

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Primary DI, Brand, Company table
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00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00850069531256AnthemMaxter Healthcare IncorporatedLZC2026-06-28
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