BLUZEN

Primary DI
10850053807098
Brand
BLUZEN
Company
Remcoda, LLC
Model
NIT101-S
Device description
Disposable Gloves, Blue, Hybrid, Nitrile, Small, 100 pcs/cs, BluZen
Published
2024-05-13
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

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
K182528000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182528000Nitrile Glove Powder Free BlackHaining Medical Products Co., Ltd.2018-11-15LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850053807098PackageGS110In Commercial Distribution
00850053807091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005380709810850053807098
00850053807091008500538070918500538070910850053807091

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

Regulatory Flags#

DUNS number
117130169
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
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
00850053807015BLUZENNIT102-S2024-05-13
00850053807022BLUZENNIT102-M2024-05-13
00850053807039BLUZENNIT102-L2024-05-13
00850053807046BLUZENNIT102-XL2024-05-13
00850053807091BLUZENNIT101-S2024-05-13
00850053807121BLUZENNIT101-XL2024-05-13
00850053807107BLUZENNIT101-M2024-05-13
00850053807114BLUZENNIT101-L2024-05-13
00810676033710BLUZENNIT104-S2023-01-19
00810676033727BLUZENNIT104-M2023-01-19
00810676033734BLUZENNIT104-L2023-01-19
00810676033741BLUZENNIT104-XL2023-01-19
00810676033772BLUZENNIT103-S2023-01-19
00810676033789BLUZENNIT103-M2023-01-19
00810676033796BLUZENNIT103-L2023-01-19
00810676033802BLUZENNIT103-XL2023-01-19
00810676034311BLUZENMNIT103-M2023-01-06
00810676034328BLUZENMNIT103-L2023-01-06
00810676034335BLUZENMNIT103-XL2023-01-06
00810676034342BLUZENMNIT103-XXL2023-01-06

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00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
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