FDA.report

Ultragard

Primary DI
00816928028039
Brand
Ultragard
Company
Ultragard
Model
L300-L
Device description
box of 100 powder free latex examination gloves, non-sterile, size Large
Published
2023-05-25
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

Related Records

Product Codes

CodeName
LYYLatex Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816928028039PackageGS110In Commercial Distribution
00816928023034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816928028039008169280280398169280280390816928028039
00816928023034008169280230348169280230340816928023034

GMDN Terms

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

Regulatory Flags

DUNS number
175840941
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
00816928026318UltragardV300-S2025-02-03
00816928026325UltragardV300-M2025-02-03
00816928026332UltragardV300-L2025-02-03
00816928026349UltragardV300-XL2025-02-03
00816928027711UltragardB300-S2025-02-03
00816928027728UltragardB300-M2025-02-03
00816928027735UltragardB300-L2025-02-03
00816928027742UltragardB300-XL2025-02-03
00816928027506UltragardN300-XS2024-03-19
00816928027551UltragardN300-XXL2024-03-19
00816928025250UltragardUGET-XXL2023-10-10
00816928025601UltragardUGNTPF-XS2023-05-25
00816928025618UltragardUGNTPF-S2023-05-25
00816928025625UltragardUGNTPF-M2023-05-25
00816928025632UltragardUGNTPF-L2023-05-25
00816928025649UltragardUGNTPF-XL2023-05-25
00816928028008UltragardL300-XS2023-05-25
00816928028015UltragardL300-S2023-05-25
00816928028022UltragardL300-M2023-05-25
00816928028046UltragardL300-XL2023-05-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
D77116100LG0GuardianICP, INC.LYY2026-03-19
D77116100MD0GuardianICP, INC.LYY2026-03-19
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
20742061700249KVPKVP International, Inc.LYY2025-08-12
00742061700252KVPKVP International, Inc.LYY2025-08-12
20742061700263KVPKVP International, Inc.LYY2025-08-12
10076490456518TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
20076490001463TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30