FDA.reportPublic FDA data

Super Flex Nitrile Exam Gloves

Primary DI
00851309000204
Brand
Super Flex Nitrile Exam Gloves
Company
NU RADIANCE INC
Model
Medium
Catalog number
GL90M
Device description
Super Flex Nitrile Exam Gloves size Medium
Published
2022-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851309000204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851309000204008513090002048513090002040851309000204

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
920-337-0201info@sentrydental.com

Regulatory Flags#

DUNS number
148149243
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815143001902Sentry Dental TC&BShade Bleach16-10012023-06-12
00815143001919Sentry Dental TC&BShade A116-10022023-06-12
00815143001926Sentry Dental TC&BShade A216-10032023-06-12
00815143001933Sentry Dental TC&BShade A316-10042023-06-12
00815143001940Sentry Dental TC&BShade C216-10052023-06-12
00851309000006NovaExtra SmallGL10XS2022-07-19
00851309000075NovaSmallGL10S2022-07-19
00851309000082NovaMediumGL10M2022-07-19
00851309000099NovaLargeGL10L2022-07-19
00851309000105NovaExtra LargeGL10XL2022-07-19
00851309000167Super Flex Nitrile Exam GlovesExtra SmallGL90XS2022-07-19
00851309000181Super Flex Nitrile Exam GlovesSmallGL90S2022-07-19
00851309000280Super Flex Nitrile Exam GlovesLargeGL90L2022-07-19
00851309000365Super Flex Nitrile Exam GlovesExtra LargeGL90XL2022-07-19
00851309000433Blue Silk Nitrile Exam GlovesExtra SmallGL96XS2022-07-19
00851309000464Blue Silk Nitrile Exam GlovesSmallGL96S2022-07-19
00851309000471Blue Silk Nitrile Exam GlovesmediumGL96m2022-07-19
00851309000488Blue Silk Nitrile Exam GloveslargeGL96L2022-07-19
00851309000495Blue Silk Nitrile Exam Glovesextra largeGL96XL2022-07-19
B77221070Classic50 Syringe Pack21072022-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
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