FDA.reportPublic FDA data

Sentinel Guardian - Nitrile

Primary DI
10850036973000
Brand
Sentinel Guardian - Nitrile
Company
Life Science Products, Inc.
Model
G-GNF12-Sm
Device description
Non-sterile powder free nitrile exam glove size small
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K161929000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161929000Palm-Pro Chemo-Guard Nitrile Powder Free Examination GloveDipped Products (Thailand) Limited2017-03-29LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850036973000PackageGS110In Commercial Distribution
00850036973003PrimaryGS10
00850036973010Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003697300010850036973000
00850036973003008500369730038500369730030850036973003
00850036973010008500369730108500369730100850036973010

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

Regulatory Flags#

DUNS number
119697365
Device count
100
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
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
00850036973348Sentinel Guardian - NitrileG-MDNF09-LG2024-12-30
00850036973386Sentinel Guardian - NitrileG-MDNF09-XL2024-12-30
10850036973345Sentinel Guardian - NitrileG-MDNF09-LG2024-12-30
10850036973383Sentinel Guardian - NitrileG-MDNF09-XL2024-12-30
00850036973331Sentinel Guardian - NitrileG-MDNF09-MED2024-12-26
10850036973338Sentinel Guardian - NitrileG-MDNF09-MED2024-12-26
00850036973324Sentinel Guardian - NitrileG-MDNF09-SM2024-12-18
10850036973321Sentinel Guardian - NitrileG-MDNF09-SM2024-12-18
00850036973003Sentinel Guardian - NitrileG-GNF12-Sm2022-09-23
00850036973027Sentinel Guardian - NitrileG-GNF12-Med2022-09-23
00850036973041Sentinel Guardian - NitrileG-GNF12-Lg2022-09-23
00850036973065Sentinel Guardian - NitrileG-GNF12-Xl2022-09-23
00850036973089Sentinel Guardian - NitrileG-GNF12-2xl2022-09-23
10850036973024Sentinel Guardian - NitrileG-GNF12-Med2022-09-23
10850036973048Sentinel Guardian - NitrileG-GNF12-Lg2022-09-23
10850036973062Sentinel Guardian - NitrileG-GNF12-Xl2022-09-23
10850036973086Sentinel Guardian - NitrileG-GNF12-2xl2022-09-23
00850036973102Sentinel Guardian - NitrileG-PNF09-Xsm2022-09-20
00850036973119Sentinel Guardian - LatexG-LF09-Xsm2022-09-20
00850036973140Sentinel Guardian - LatexG-LF09-Sm2022-09-20

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