FDA.reportPublic FDA data

Essential Cares

Primary DI
10850018936689
Brand
Essential Cares
Company
Essential Cares Supplies, Inc.
Model
MGLVNPF235BL-XL-ES
Catalog number
MGLVNPF235BL-XL-ES
Device description
Nitrile Glove Powder-Free Finger Textured Blue Essential Cares X-Large 200pc/Bx 10Bx/Cs
Published
2023-03-02
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
K212735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212735000Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)Xingyu Medical Tech Co., Ltd.2022-01-11LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018936699PackageGS110In Commercial Distribution
00850018936729PackageGS110In Commercial Distribution
00850018936682PrimaryGS10
00850018936705PrimaryGS10
10850018936689Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018936699008500189366998500189366990850018936699
00850018936729008500189367298500189367290850018936729
00850018936682008500189366828500189366820850018936682
00850018936705008500189367058500189367050850018936705
1085001893668910850018936689

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

Contacts#

Phone, Email table
PhoneEmail
2137431402info@essentialcares.com

Regulatory Flags#

DUNS number
809399350
Device count
200
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
true
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
00850018936712Essential CaresMGWNISOSPP20ECYLESMGWNISOSPP20ECYLES2023-03-17
00850018936408Essential CaresMLCTWTKCCNP-XXL-ESMLCTWTKCCNP-XXL-ES2023-05-26
00850018936897Essential CaresMLCTWTKCCNP-5XL-ESMLCTWTKCCNP-5XL-ES2023-05-26
00850018936910Essential CaresMLCTBLKCCNP-S-ESMLCTBLKCCNP-S-ES2023-05-26
00850018936934Essential CaresMLCTBLKCCNP-M-ESMLCTBLKCCNP-M-ES2023-05-26
00850018936958Essential CaresMLCTBLKCCNP-L-ESMLCTBLKCCNP-L-ES2023-05-26
00850018936972Essential CaresMLCTBLKCCNP-XL-ESMLCTBLKCCNP-XL-ES2023-05-26
00850018936996Essential CaresMLCTBLKCCNP-XXL-ESMLCTBLKCCNP-XXL-ES2023-05-26
00850051455010Essential CaresMLCTBLKCCNP-XXXL-ESMLCTBLKCCNP-XXXL-ES2023-05-26
00850051455034Essential CaresMLCTBLKCCNP-XXXXL-ESMLCTBLKCCNP-XXXXL-ES2023-05-26
00850051455058Essential CaresMLCTBLKCCNP-5XL-ESMLCTBLKCCNP-5XL-ES2023-05-26
00850018936507Essential CaresMLCTWTKCCNP-XXL-ESMLCTWTKCCNP-XXL-ES2023-05-26
00850018936903Essential CaresMLCTWTKCCNP-5XL-ESMLCTWTKCCNP-5XL-ES2023-05-26
00850018936927Essential CaresMLCTBLKCCNP-S-ESMLCTBLKCCNP-S-ES2023-05-26
00850018936941Essential CaresMLCTBLKCCNP-M-ESMLCTBLKCCNP-M-ES2023-05-26
00850018936965Essential CaresMLCTBLKCCNP-L-ESMLCTBLKCCNP-L-ES2023-05-26
00850018936989Essential CaresMLCTBLKCCNP-XL-ESMLCTBLKCCNP-XL-ES2023-05-26
00850051455027Essential CaresMLCTBLKCCNP-XXXL-ESMLCTBLKCCNP-XXXL-ES2023-05-26
00850051455041Essential CaresMLCTBLKCCNP-XXXXL-ESMLCTBLKCCNP-XXXXL-ES2023-05-26
00850018936361Essential CaresMLCTWTKCCNP-L-ESMLCTWTKCCNP-L-ES2023-03-30

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Primary DI, Brand, Company table
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