FDA.reportPublic FDA data

Oasis

Primary DI
B031AHS91
Brand
Oasis
Company
American Health Service Sales Corporation
Model
AHS-9
Device description
SURGEON GLOVES,LATEX,SIZE 9
Published
2024-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151114000Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with proteinSt. Marys Rubbers Pvt, Ltd.2015-12-11KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B031AHS91PackageHIBCC50In Commercial Distribution
B031AHS92PackageHIBCC10In Commercial Distribution
B031AHS90PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical 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 at the surgical site; 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 contamination from microorganisms. 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 table
Method

Regulatory Flags#

DUNS number
556115970
Device count
1
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
true
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B031AH01T25160AHSAH01T25162016-03-31
B031AH01T27130AHSAH01T27132016-03-31
B031AH03L18250AHSAH03L18252016-03-31
B031AH03L18380AHSAH03L18382016-03-31
B031AH03L20250AHSAH03L20252016-03-31
B031AH03L20380AHSAH03L20382016-03-31
B031AH03L21250AHSAH03L21252016-03-31
B031AH03L22190AHSAH03L22192016-03-31
B031AH03L22250AHSAH03L22252016-03-31
B031AH03L22380AHSAH03L22382016-03-31
B031AH03L23250AHSAH03L23252016-03-31
B031AH03L25160AHSAH03L25162016-03-31
B031AH03L25250AHSAH03L25252016-03-31
B031AH03L25380AHSAH03L25382016-03-31
B031AH03L27380AHSAH03L27382016-03-31
B031AH03S22190AHSAH03S22192016-03-31
B031AH05M29130AHSAH05M29132016-03-31
B031AH05M2913400AHSAH05M2913402016-03-31
B031AH10M29130AHSAH10M29132016-03-31
B031AH10M2913400AHSAH10M2913402016-03-31

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Primary DI, Brand, Company table
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