FDA.reportPublic FDA data

HANDCOVERS

Primary DI
00850051992270
Brand
HANDCOVERS
Company
Balco Industries Inc.
Model
PNK4002
Device description
4 Mil Powder-Free Rose Nitrile Gloves, Size Medium
Published
2024-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
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
00850051992270PackageGS110In Commercial Distribution
00850051992263PrimaryGS10
30850051992264Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051992270008500519922708500519922700850051992270
00850051992263008500519922638500519922630850051992263
3085005199226430850051992264

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
055891774
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00850051992263HANDCOVERSPNK40022024-06-17
00850051992287HANDCOVERSPNK40032024-06-17
00850051992300HANDCOVERSPNK40042024-06-17
00850051992294HANDCOVERSPNK40032024-06-17
00850051992317HANDCOVERSPNK40042024-06-17
00850051992249HANDCOVERSPNK40012024-06-15
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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00850084857379MedClickMedClick LLCLZA2026-07-22
00850084857386MedClickMedClick LLCLZA2026-07-22
00850084857393MedClickMedClick LLCLZA2026-07-22
00850084857409MedClickMedClick LLCLZA2026-07-22
05060264110056Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110070Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110094Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
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00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
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