FDA.reportPublic FDA data

McKesson

Primary DI
00612479150072
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
14-020 XL
Device description
MODULON POWDER FREE LATEX GLOVES TEXTURED NON-STERILE NATURAL OFF WHITE
Published
2020-06-25
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
LYYLatex Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479150072PackageGS110In Commercial Distribution
00612479150065PrimaryGS10
00612479235779Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479150072006124791500726124791500720612479150072
00612479150065006124791500656124791500650612479150065
00612479235779006124792357796124792357790612479235779

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
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
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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Primary DI, Brand, Company table
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D77116100SM0GuardianICP, INC.LYY2026-03-19
D77116100XL0GuardianICP, INC.LYY2026-03-19
D77116100XS0GuardianICP, INC.LYY2026-03-19
40080196762744MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
40080196762751MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
40080196762775MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
10888277703582MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
00810094090913ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090920ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090937ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090944ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
00810094090951ShieldMaxxECON DISPOSABLE SUPPLIES, INCLYY2026-02-01
D1057115XS9MacTouch Surgimac LLCLYY2025-08-14
D1057115XSCS9MacTouch Surgimac LLCLYY2025-08-14
D1057116S9MacTouch Surgimac LLCLYY2025-08-14
D1057116SCS9MacTouch Surgimac LLCLYY2025-08-14
D1057117M9MacTouch Surgimac LLCLYY2025-08-14
D1057117MCS9MacTouch Surgimac LLCLYY2025-08-14
D1057118L9MacTouch Surgimac LLCLYY2025-08-14
D1057118LCS9MacTouch Surgimac LLCLYY2025-08-14
D1057119XL9MacTouch Surgimac LLCLYY2025-08-14
D1057119XLCS9MacTouch Surgimac LLCLYY2025-08-14
20742061700232KVPKVP International, Inc.LYY2025-08-12
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20742061700263KVPKVP International, Inc.LYY2025-08-12
10076490456518TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
20076490001463TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30