FDA.reportPublic FDA data

Ambi-Gard

Primary DI
G5398670M2
Brand
Ambi-Gard
Company
Saf-T-Gard International, Inc.
Model
8670/M
Catalog number
8670/M
Device description
Ambi-Gard Blue Nitrile Exam Gloves, Size M
Published
2023-10-12
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

Contact Domains#

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
G5398670M2PackageHIBCC1000In Commercial Distribution
G5398670M1PrimaryHIBCC0
G5398670M0Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8472911600CustomerService@saftgard.com

Regulatory Flags#

DUNS number
025199415
Device count
100
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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G539MM3S1Saf-T-GardMM-3SMM-3S2026-09-21
G539MM3S2Saf-T-GardMM-3SMM-3S2026-09-21
G539MM3SB1Saf-T-GardMM-3SBMM-3SB2026-09-21
G539MM3SB2Saf-T-GardMM-3SBMM-3SB2026-09-21
G53986702XL1Ambi-Gard8670/2XL8670/2XL2023-10-12
G5398670L1Ambi-Gard8670/L8670/L2023-10-12
G5398670M1Ambi-Gard8670/M8670/M2023-10-12
G5398670S1Ambi-Gard8670/S8670/S2023-10-12
G5398670XL1Ambi-Gard8670/XL8670/XL2023-10-12
G53986702XL2Ambi-Gard8670/2XL8670/2XL2023-10-12
G5398670L2Ambi-Gard8670/L8670/L2023-10-12
G5398670S2Ambi-Gard8670/S8670/S2023-10-12
G5398670XL2Ambi-Gard8670/XL8670/XL2023-10-12
G5398670XS1Ambi-Gard8670/XS86702023-10-12

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