FDA.reportPublic FDA data

HANDCOVERS

Primary DI
00850051992249
Brand
HANDCOVERS
Company
Balco Industries Inc.
Model
PNK4001
Device description
4 Mil Powder-Free Rose Nitrile Gloves, Size Small
Published
2024-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K222103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222103000Nitrile Patient Examination Gloves, Powder Free, Pink ColorShandong Yinghng Medical Products Co., Ltd.2023-08-24LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850051992256PackageGS110In Commercial Distribution
00850051992249PrimaryGS10
30850051992240Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051992256008500519922568500519922560850051992256
00850051992249008500519922498500519922490850051992249
3085005199224030850051992240

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
055891774
Device count
100
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850051992263HANDCOVERSPNK40022024-06-17
00850051992287HANDCOVERSPNK40032024-06-17
00850051992300HANDCOVERSPNK40042024-06-17
00850051992270HANDCOVERSPNK40022024-06-17
00850051992294HANDCOVERSPNK40032024-06-17
00850051992317HANDCOVERSPNK40042024-06-17
00850051992256HANDCOVERSPNK40012024-06-15
00850051992003HANDCOVERSPFN40012023-05-30
00850051992027HANDCOVERSPFN40022023-05-30
00850051992041HANDCOVERSPFN40032023-05-30
00850051992065HANDCOVERSPFN40042023-05-30
00850051992089HANDCOVERSBKN60012023-05-30
00850051992102HANDCOVERSBKN60022023-05-30
00850051992126HANDCOVERSBKN60032023-05-30
00850051992140HANDCOVERSBKN60042023-05-30
00850051992164HANDCOVERSBKN40012023-07-01
00850051992188HANDCOVERSBKN40022023-07-01
00850051992201HANDCOVERSBKN40032023-07-01
00850051992225HANDCOVERSBKN40042023-07-01
00850051992171HANDCOVERSBKN40012023-07-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850016052056NiTouchKasa Trading, LLCLZA2026-08-03
10840064641262Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641279Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641286Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641293Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
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10840064641330Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
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10840064641354Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
00850016052018NiTouchKasa Trading, LLCLZA2026-08-02
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00199536000049BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
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00860010400906LuvatekR&C Imports LLCLZA2026-07-29
00860010400920LuvatekR&C Imports LLCLZA2026-07-29
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00850084857331MedClickMedClick LLCLZA2026-07-22
00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22