FDA.reportPublic FDA data

AirSoft

Primary DI
10810007660254
Brand
AirSoft
Company
HOURGLASS INTERNATIONAL INC
Model
902
Device description
Nitrile Powder Free Examination Gloves, M, 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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810007660251PrimaryGS10
00810007660257Unit of UseGS10
10810007660254Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081000766025120810007660251
00810007660257008100076602578100076602570810007660257
1081000766025410810007660254

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
100
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

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Primary DI, Brand, Company table
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00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
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10304040194048EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194055EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194062EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194079EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194086EssentialsHENRY SCHEIN, INC.LZA2026-06-25
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00840546402391sunnycareAgio Group Inc.LZA2026-06-10
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
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04