FDA.reportPublic FDA data

BEASTEK

Primary DI
00810160180036
Brand
BEASTEK
Company
Supmedics Inc.
Model
BTN1445
Device description
Medical Examination Nitrile Gloves: KG-1101 (XL size)
Published
2024-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K203593000
K222714000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203593000Patient Examination GlovesGuangdong Kingfa Sci. & Tech.Co., Ltd.2021-03-19LZA
K222714000Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy DrugsGuangdong Kingfa Sci. & Tech.Co., Ltd.2022-10-07LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810160180159PackageGS110In Commercial Distribution
00810160180036PrimaryGS10
00810160181941Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810160180159008101601801598101601801590810160180159
00810160180036008101601800368101601800360810160180036
00810160181941008101601819418101601819410810160181941

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width120Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
107150886
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810160180005BEASTEKBTN14422024-11-04
00810160180012BEASTEKBTN14432024-11-04
00810160180043BeastekBTN24422024-10-02
00810160183549supUNE-XL-151052026-01-26
08101601833584supUNE-S-131022026-01-26
08101601833652supUNE-M-131032026-01-26
08101601833720supUNE-L-131042026-01-26
08101601833898supUNE-XL-131052026-01-26
08101601834338supUNE-S-141022026-01-26
08101601834406supUNE-M-141032026-01-26
08101601834574supUNE-L-141042026-01-26
08101601834642supUNE-XL-141052026-01-26
08101601835182supUNE-S-151022026-01-26
08101601835250supUNE-M-151032026-01-26
08101601835328supUNE-L-151042026-01-26
08101601835946supUNE-S-161022026-01-26
08101601836004supUNE-M-161032026-01-26
08101601836172supUNE-L-161042026-01-26
08101601836240supUNE-XL-161052026-01-26
08101601836790SUPUNM-S-141122026-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
00768627017282Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
10840330702208ProCureTwin Med, LLCLZA2026-06-01
10840330702215ProCureTwin Med, LLCLZA2026-06-01
10840330702222ProCureTwin Med, LLCLZA2026-06-01
10840330702239ProCureTwin Med, LLCLZA2026-06-01
10840330702246ProCureTwin Med, LLCLZA2026-06-01
10840330706756ProCureTwin Med, LLCLZA2026-06-01
10840330706763ProCureTwin Med, LLCLZA2026-06-01
10840330706770ProCureTwin Med, LLCLZA2026-06-01
10840330706787ProCureTwin Med, LLCLZA2026-06-01
10840330706794ProCureTwin Med, LLCLZA2026-06-01
10860015093728MaadhoMaadho Distributors Inc.LZA2026-06-01
10860015093735MaadhoMaadho Distributors Inc.LZA2026-06-01
10860015093742MaadhoMaadho Distributors Inc.LZA2026-06-01
10860015093759MaadhoMaadho Distributors Inc.LZA2026-06-01
10840330702000ProCureTwin Med, LLCLZA2026-05-29
10840330702024ProCureTwin Med, LLCLZA2026-05-29
10840330702048ProCureTwin Med, LLCLZA2026-05-29
10840330702062ProCureTwin Med, LLCLZA2026-05-29
10840330702086ProCureTwin Med, LLCLZA2026-05-29
10840330702109ProCureTwin Med, LLCLZA2026-05-29
10840330702123ProCureTwin Med, LLCLZA2026-05-29
10840330702147ProCureTwin Med, LLCLZA2026-05-29
10840330702161ProCureTwin Med, LLCLZA2026-05-29
10840330702185ProCureTwin Med, LLCLZA2026-05-29