FDA.reportPublic FDA data

Shield Gloves

Primary DI
00840369321800
Brand
Shield Gloves
Company
B D G Wrap-Tite, Inc.
Model
GLNMPFB3-XL
Device description
Black Nitrile Glove, Exam Grade, Powder Free, Fully Textured, XL, Inner Pack
Published
2024-11-15
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
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230002000Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy DrugsMah Sing Healthcare Sdn. Bhd.2023-03-24LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840369321817PrimaryGS10
00840369321800Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840369321817008403693218178403693218170840369321817
00840369321800008403693218008403693218000840369321800

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
076901110
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
00840369313140Shield GlovesGLNMPFL6-S2024-11-18
00840369313171Shield GlovesGLNMPFL6-M2024-11-19
00840369313201Shield GlovesGLNMPFL6-L2024-11-19
00840369313232Shield GlovesGLNMPFL6-XL2024-11-19
00840369315359Shield GlovesGLNMPFB6-S2024-11-15
00840369321848Shield GlovesGLNMPFL6-2XL2024-11-19
00850046161582Shield GlovesGLNMPFL-2XL2023-02-22
00850046161612Shield GlovesGLNMPFL-XL2022-11-25
00850046161650Shield GlovesGLNMPFL-L2022-11-25
00850046161681Shield GlovesGLNMPFL-M2022-11-25
00850046161711Shield GlovesGLNMPFL-S2022-11-25
00850046161865Shield GlovesGLNMPFB6-M2022-12-06
00850046161896Shield GlovesGLNMPFB6-L2022-12-06
00850046161926Shield GlovesGLNMPFB6-XL2022-12-06
00850046161957Shield GlovesGLNMPFB6-2XL2022-12-06
00840369300010Shield GlovesGLVNMPFB-S2024-11-19
00840369300041Shield GlovesGLVNMPFB-M2024-11-19
00840369300072Shield GlovesGLVNMPFB-L2024-11-19
00840369300102Shield GlovesGLVNMPFB-XL2024-11-19
00840369321602Shield GlovesGLNMPFL3-S2024-11-13

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