FDA.reportPublic FDA data

FreeStyle

Primary DI
00810007660370
Brand
FreeStyle
Company
HOURGLASS INTERNATIONAL INC
Model
1104
Device description
Nitrile Powder Free Examination Gloves, XL, Tested for Use with Chemotherapy Drugs.
Published
2021-12-01
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
LZAPolymer Patient Examination Glove
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810007660377PrimaryGS10
00810007660370Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000766037710810007660377
00810007660370008100076603708100076603700810007660370

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
026777252
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810007662336NUSA2002026-01-01
00810007662343NUSA2012026-01-01
00810007662350NUSA2022026-01-01
00810007662367NUSA2032026-01-01
00810007662374NUSA2042026-01-01
00810007662381NUSA2002026-01-01
00810007662398NUSA2012026-01-01
00810007662404NUSA2022026-01-01
00810007662411NUSA2032026-01-01
00810007662428NUSA2042026-01-01
00810007662480HANDPRO55002025-12-15
00810007662497HANDPRO55012025-12-15
00810007662503HANDPRO55022025-12-15
00810007662510HANDPRO55032025-12-15
00810007662527HANDPRO55042025-12-15
00810007662596HANDPRO55052025-12-15
00810007662534HANDPRO55002025-12-15
00810007662541HANDPRO55012025-12-15
00810007662558HANDPRO55022025-12-15
00810007662565HANDPRO55032025-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00196633795946Kirkland SignatureCostco Wholesale CorporationLZA2026-06-17
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
00842942019579PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019586PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019593PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019609PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019616PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019623PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019630PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019647PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019654PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019661PRIMEDpriMED Medical Products IncLZA2026-03-12
00810194400148AiraAIRA, LLCLZA2026-01-16
00810194400193AiraAIRA, LLCLZA2026-01-16
00842942014154PRIMEDpriMED Medical Products IncLZC2025-11-18
00842942014154PRIMEDpriMED Medical Products IncLZA2025-11-18