FDA.reportPublic FDA data

US Medical Glove

Primary DI
00850060649080
Brand
US Medical Glove
Company
US Medical Glove Company L.L.C.
Model
Blue Small
Catalog number
1001-10
Device description
Nitrile Exam Gloves (Chemotherapy Drug Tested) 5MIL BLUE FDA 510(k) K223748 Size: Small Master Carton
Published
2024-01-17
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

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223748000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223748000Nitrile Exam Gloves (Chemotherapy Drug Tested)Us Medical Glove Company, LLC2023-01-13LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850060649097PrimaryGS10
00850060649103PrimaryGS10
00850060649080Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850060649097008500606490978500606490970850060649097
00850060649103008500606491038500606491030850060649103
00850060649080008500606490808500606490800850060649080

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
855-438-8764sales@usmg.us

Regulatory Flags#

DUNS number
117764502
Device count
1000
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
00850060649110US Medical GloveBlue Medium1002-102024-01-17
00850060649141US Medical GloveBlue Large1003-102024-01-17
00850060649172US Medical GloveBlue Extra Large1004-102024-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10194346659194EquateWAL-MART STORES, INC.LZA2026-03-24
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