FDA.reportPublic FDA data

Night Angel

Primary DI
06531950022520
Brand
Night Angel
Company
ADENNA LLC
Model
NGL225
Catalog number
NGL225
Device description
NIGHT ANGEL® Disposable Nitrile Exam Gloves, Powder Free, Black, 4 mil, Medium, 100/bx, 10 bxs/cs
Published
2020-04-20
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

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
K151528000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151528000Powder Free Nitrile (Black) Examination GlovesGallant Quality Sdn. Bhd.2015-10-09LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06531950022520PackageGS110In Commercial Distribution
00653195002252PrimaryGS10
70653195002251Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
06531950022520065319500225206531950022520
00653195002252006531950022526531950022520653195002252
7065319500225170653195002251

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-sterileA non-sterile 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
8003219832info@hospeco.com

Regulatory Flags#

DUNS number
112042723
Device count
100
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
false
Expiration date on label
false
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
00653195002207Night AngelNGL220NGL2202020-04-22
00653195002221AdennaNGL222NGL2222020-04-20
00653195002252Night AngelNGL225NGL2252020-04-20
00653195002269Night AngelNGL226NGL2262020-04-17
00653195002283Night AngelNGL228NGL2282020-04-20
00653195002306AdennaVPF230VPF2302020-04-20
00653195002320AdennaVPF232VPF2322020-04-20
00653195002351AdennaVPF235VPF2352020-04-20
00653195002368AdennaVPF236VPF2362020-04-20
00653195002382AdennaVPF238VPF2382020-04-20
00653195002603AdennaGLD260GLD2602020-04-17
00653195002627AdennaGLD262GLD2622020-04-17
00653195002658AdennaGLD265GLD2652020-04-17
00653195002665AdennaGLD266GLD2662020-04-17
00653195002689AdennaGLD268GLD2682020-04-17
00653195005505AdennaAdennaAdenna2020-04-17
00653195005529AdennaPLT552PLT5522020-04-17
00653195005550AdennaPLT555PLT5552020-04-17
00653195005567AdennaPLT556PLT5562020-04-17
00653195005581AdennaPLT558PLT5582020-04-17

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08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
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