FDA.reportPublic FDA data

Safety First

Primary DI
00724351222439
Brand
Safety First
Company
Austin Pang Gloves Mfg (u.s.a.) Corp.
Model
8773AS
Catalog number
8773AS
Device description
Nitrile Powder Free Examination Glove, Blue
Published
2024-07-31
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
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
00724351222439PackageGS110In Commercial Distribution
00724351222422PrimaryGS10
00724351263524Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724351222439007243512224397243512224390724351222439
00724351222422007243512224227243512224220724351222422
00724351263524007243512635247243512635240724351263524

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
Storage Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
072794423
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724351225720Elite8723XS8723XS2023-11-21
00724351225744Elite8723XXL8723XXL2023-11-21
00724351256434Elite8703AS8703AS2023-11-21
00724351256441Elite8703AM8703AM2023-11-21
00724351256458Elite8703AL8703AL2023-11-21
00724351256465Elite8703AXL8703AXL2023-11-21
00724351996873Elite8723XL8723XL2023-11-21
00724351996880Elite8723L8723L2023-11-21
00724351996897Elite8723M8723M2023-11-21
00724351996903Elite8723S8723S2023-11-21
00671451132284Pasco Wear-A-Day GlovePASCO952XLPASCO952XL2024-10-15
00671451170729Pasco Wear-A-Day GlovePASCO952LPASCO952L2024-10-15
00671451183866Pasco Wear-A-Day GlovePASCO952XLPASCO952XL2024-10-15
00671451183859Pasco Wear-A-Day GlovePASCO952LPASCO952L2024-10-15
00724351122401Elite Protective Extra8720L8720L2024-07-31
00724351122418Elite Protective Extra8720M8720M2024-07-31
00724351122425Elite Protective Extra8720S8720S2024-07-31
00724351122432Elite Protective Extra8720XL8720XL2024-07-31
00724351222408Safety First8773AXS8773AXS2024-07-31
00724351222422Safety First8773AS8773AS2024-07-31

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
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
10840330702239ProCureTwin Med, LLCLZA2026-06-01