FDA.reportPublic FDA data

5R MED

Primary DI
06973675390230
Brand
5R MED
Company
5R MED Instruments (CHENGDU) Co., Ltd
Model
5R-GVN
Device description
Disposable Nitrle Gloves
Published
2021-08-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210776000Nitrile Examination Gloves5r Med Instruments (Chengdu) Co., Ltd.2021-07-12LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973675390230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973675390230069736753902306973675390230

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.

Regulatory Flags#

DUNS number
554529132
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
069736753900015R MED5R-GVN2021-08-10
069736753910085R MED5R GVN2021-08-10
069736753912135R MED5R-DM2021-08-10
069736753920365R MED5R-DM2021-08-10
069736753922415R MED5R-DM2021-08-10
069736753925625R MED5R-DM2021-08-10
069736753929205R MED5R-GVN2021-08-10
069736753930575R MED5R-GVC2021-08-10
069736753931565R MED5R-GVC2021-08-10
069736753933235R MED5R-GVC2021-08-10
069736753950065R MED5R-GV2021-08-10
069736753900635R MED5R-GVN2021-08-09
069736753916955R MED5RMED 5R-GVN2021-08-09

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Primary DI, Brand, Company table
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