FDA.reportPublic FDA data

Bodyguard

Primary DI
00662956500456
Brand
Bodyguard
Company
Fastenal Company
Model
M-816E
Device description
MEDIUM SERIES 814E 4 MIL BLUE NITRILE EXAM GRADE POWDER-FREE BODY GUARD[REG] DISPOSABLE GLOVE
Published
2025-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K202356000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202356000Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)Kanglongda Vietnam Protection Technology Company Limited2021-03-02LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30662956500457PackageGS1100In Commercial Distribution
50662956500451PackageGS110In Commercial Distribution
00662956500456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3066295650045730662956500457
5066295650045150662956500451
00662956500456006629565004566629565004560662956500456

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
042653634
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00662956201063Body Guard[Medium Series 814E2026-09-30
00662956201285Body Guard[814E Large2026-09-30
00662956202558Body Guard814E XL2026-09-30
00662956203258Body GuardLarge Series 814E2026-09-30
00662956203661Bodyguard814E Small2026-09-30
00662956203760Bodyguard814E Med2026-09-30
00662956205320Body GuardSmall Series 814E2026-09-30
00662956210171Body GuardXL Series 814E2026-09-30
00662956500463BodyguardL-816E2025-02-21
00662956500432BodyguardS-814E2025-02-21
00662956500470BodyguardXL-814E2025-02-21
30662956500433BodyguardS-814E2025-02-21
30662956500457BodyguardM-816E2025-02-21
30662956500464BodyguardL-816E2025-02-21
30662956500471BodyguardXL-816E2025-02-21
00662956390040Bodyguard815 BK M2023-05-24
00662956390316Bodyguard815 BK S2023-05-24
00662956483216Bodyguard815 BK XL2023-05-24
00662956211550Bodyguard816EI VP2023-05-24
30662956935563Bodyguard815 BK M2023-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054870544BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870551BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870568BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870575BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870582BAYLAB USABaylab USA, LLCLZA2026-10-01
00662956201063Body Guard[Fastenal CompanyLZA2026-09-30
00662956201285Body Guard[Fastenal CompanyLZA2026-09-30
00662956202558Body GuardFastenal CompanyLZA2026-09-30
00662956203258Body GuardFastenal CompanyLZA2026-09-30
00662956203661BodyguardFastenal CompanyLZA2026-09-30
00662956203760BodyguardFastenal CompanyLZA2026-09-30
00662956205320Body GuardFastenal CompanyLZA2026-09-30
00662956210171Body GuardFastenal CompanyLZA2026-09-30
10860015093766MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093773MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093780MaadhoMaadho Distributors Inc.LZA2026-09-24
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00199536900820BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
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00811114033026TopGripUnisafe Inc.LZA2026-08-14
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
00850016052049NiTouchKasa Trading, LLCLZA2026-08-03
00850016052056NiTouchKasa Trading, LLCLZA2026-08-03