Inspire

Primary DI
00816554015472
Brand
Inspire
Company
K2 Health Products LLC
Model
INSTFNG-XL
Device description
Inspire TRUE FEEL Nitrile Gloves Size X-Large
Published
2024-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170393000Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)Zibo Chengxun Automatic Device Co., Ltd.2017-05-09LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816554015479PackageGS110In Commercial Distribution
00816554015472PrimaryGS10
50816554015477Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081655401547910816554015479
00816554015472008165540154728165540154720816554015472
5081655401547750816554015477

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(718)451-4444info@k2health.com

Regulatory Flags#

DUNS number
800616612
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816554015403InspireINSVPBBLUG-S2024-09-17
00816554015410InspireINSVPBBLUG-M2024-09-17
00816554015427InspireINSVPBBLUG-L2024-09-17
00816554015434InspireINSVPBBLUG-XL2024-09-17
10816554015400InspireINSVPBBLUG-S2024-09-17
10816554015417InspireINSVPBBLUG-M2024-09-17
10816554015424InspireINSVPBBLUG-L2024-09-17
10816554015431InspireINSVPBBLUG-XL2024-09-17
00816554015441InspireINSTFNG-S2024-09-11
00816554015458InspireINSTFNG-M2024-09-11
00816554015465InspireINSTFNG-L2024-09-11
10816554015448InspireINSTFNG-S2024-09-11
10816554015455InspireINSTFNG-M2024-09-11
10816554015462InspireINSTFNG-L2024-09-11
10816554015479InspireINSTFNG-XL2024-09-11
00816554015120InspireINSLBNG-S2024-06-21
00816554015137InspireINSLBNG-M2024-06-21
00816554015144InspireINSLBNG-L2024-06-21
00816554015151InspireINSLBNG-XL2024-06-21
00816554015168InspireINSLBNG-XXL2024-06-21

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