FDA.reportPublic FDA data

Decontam Exam Gloves

Primary DI
10848956007356
Brand
Decontam Exam Gloves
Company
HEALTHMARK INDUSTRIES CO., INC.
Model
TDG-4-50
Catalog number
TDG-4-50
Published
2024-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221157000JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.2022-08-30LZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848956007356PrimaryGS10
00848956007359Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084895600735610848956007356
00848956007359008489560073598489560073590848956007359

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
057680480
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848956021263Sanizyme60030008332026-05-22
00848956021287Sanizyme60030008352026-05-22
00848956021294Sanizyme60030008362026-05-22
00848956021317Sanizyme60030008342026-05-22
10848956020010SAFEGUARD PROSGP112SGP1122025-10-20
10848956020027SAFEGUARD PROSGP115SGP1152025-10-20
10848956020034SAFEGUARD PROSGP1182025-10-20
10848956020041SAFEGUARD PROSGP124SGP1242025-10-20
10848956020058SAFEGUARD PROSGP130SGP1302025-10-20
10848956020065SAFEGUARD PROSGP136 SGP136 2025-10-20
10848956020072SAFEGUARD PROSGP212 SGP212 2025-10-20
10848956020089SAFEGUARD PROSGP218SGP2182025-10-20
10848956020096SAFEGUARD PROSGP224SGP2242025-10-20
10848956020102SAFEGUARD PROSGP230 SGP230 2025-10-20
10848956020119SAFEGUARD PROSGP236 SGP236 2025-10-20
10848956020126SAFEGUARD PROSGP324SGP3242025-10-20
10848956020133SAFEGUARD PROSGP330SGP3302025-10-20
10848956020140SAFEGUARD PROSGP336 SGP336 2025-10-20
10848956020157SAFEGUARD PROSGP345SGP3452025-10-20
10848956020164SAFEGUARD PROSGP354 SGP354 2025-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10809160541722HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541746HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541753HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
10809160541470HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
10809160541487HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
10809160541494HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
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00199972000672CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
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00850069531058Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531065Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531133Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15