FDA.reportPublic FDA data

Henry Schein

Primary DI
20304040101555
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1132564
Catalog number
1132564
Device description
Precise Fit PF Latex Glove
Published
2020-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
20304040101555PackageGS110In Commercial Distribution
10304040101558PrimaryGS10
00304040101551Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404010155520304040101555
1030404010155810304040101558
00304040101551003040401015513040401015510304040101551

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-sterileA non-sterile 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 talcum powder and it does not have antimicrobial features. 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
012430880
Device count
100
DM exempt
false
Premarket exempt
true
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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Primary DI, Brand, Company table
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D77116100XL0GuardianICP, INC.LYY2026-03-19
D77116100XS0GuardianICP, INC.LYY2026-03-19
40080196762744MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
40080196762751MEDLINEMEDLINE INDUSTRIES, INC.LYY2026-02-10
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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
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