FDA.reportPublic FDA data

Professional Medical Surgical Supply, Inc. d / b / a International Direct

Primary DI
00814125010048
Brand
Professional Medical Surgical Supply, Inc. d / b / a International Direct
Company
PROFESSIONAL MEDICAL-SURGICAL SUPPLY, INCORPORATED
Model
600-NW14
Catalog number
600-NW14
Device description
Embrace Nitrile Exam Gloves - X Large
Published
2020-07-24
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
LYZVinyl patient examination glove
LZAPolymer patient examination glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814125010045PackageGS110In Commercial Distribution
00814125010048PrimaryGS10
00814125011458Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081412501004510814125010045
00814125010048008141250100488141250100480814125010048
00814125011458008141250114588141250114580814125011458

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)648-5190ksimanis@promedsupply.com

Regulatory Flags#

DUNS number
042850073
Device count
100
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00898777001227Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V111600-V1112020-08-12
00898777001234Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V112600-V1122020-08-12
00898777001241Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V113600-V1132020-08-12
00898777001258Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V114600-V1142020-08-12
20898777001221Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V111600-V1112020-08-12
10898777001231Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V112600-V1122020-08-12
10898777001248Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V113600-V1132020-08-12
10898777001255Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V114600-V1142020-08-12
00814125010871Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V111-BX600-V111-BX2020-07-24
00814125010888Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V112-BX600-V112-BX2020-07-24
00814125010895Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V113-BX600-V113-BX2020-07-24
00814125010901Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V114-BX600-V114-BX2020-07-24
00814125010024Professional Medical Surgical Supply, Inc. d / b / a International Direct600-NW12600-NW122020-07-24
00814125010031Professional Medical Surgical Supply, Inc. d / b / a International Direct600-NW13600-NW132020-07-24
00814125010475Professional Medical Surgical Supply, Inc. d / b / a International Direct600-NW11600-NW112020-07-24
00898777001340Professional Medical Surgical Supply, Inc. d / b / a International Direct600-SS11600-SS112020-07-24
00898777001944Professional Medical Surgical Supply, Inc. d / b / a International Direct600-SS12600-SS122020-07-24
00898777001951Professional Medical Surgical Supply, Inc. d / b / a International Direct600-SS13600-SS132020-07-24
00898777001968Professional Medical Surgical Supply, Inc. d / b / a International Direct600-SS14600-SS142020-07-24
10814125010021Professional Medical Surgical Supply, Inc. d / b / a International Direct600-NW12600-NW122020-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133836MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00713733712835MeijerMEIJER, INC.LYZ2026-06-05
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