FDA.reportPublic FDA data

Dealmed

Primary DI
00817415021205
Brand
Dealmed
Company
DEALMED MEDICAL SUPPLIES LLC
Model
787560
Catalog number
787560
Device description
Glove Exam Nitrile N/S PF Small Purple, 300/Bx
Published
2020-09-11
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
K071740000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071740000CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVESMedtexx Manufacturing Sdn. Bhd.2007-10-04LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817415021205PackageGS110In Commercial Distribution
00817415021199PrimaryGS10
00817415020178Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817415021205008174150212058174150212050817415021205
00817415021199008174150211998174150211990817415021199
00817415020178008174150201788174150201780817415020178

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(718)475-1922celazary@dealmed.com

Regulatory Flags#

DUNS number
068586441
Device count
300
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817415020086Dealmed7875307875302022-08-29
00859140003125Dealmed7875207875202022-08-29
10817415021653Dealmed7831327831322021-09-30
10817415021844DEALMED7838227838222021-09-17
00859140003750Dealmed8591400037577830432020-09-11
00859140003798Dealmed7838047838042020-12-04
00817415021861Dealmed7864017864012021-04-26
00817415021878Dealmed7864027864022021-04-26
00817415021885Dealmed7864037864032021-04-26
00817415023049Dealmed7864047864042022-07-18
00817415023087Dealmed7864087864082022-07-28
00817415023063Dealmed7864067864062022-07-28
00817415020468Dealmed7836197836192020-12-04
00817415020512Dealmed7835037835032020-12-04
00817415021069Dealmed7885257885252021-06-11
00817415022370Dealmed7832527832522022-08-29
00817415022387Dealmed7832537832532022-08-29
00817415022394Dealmed7832547832542022-08-29
00817415022400Dealmed8079458079452021-10-25
00817415021083Dealmed7830327830322020-12-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
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
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
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10840330702222ProCureTwin Med, LLCLZA2026-06-01
10840330702239ProCureTwin Med, LLCLZA2026-06-01
10840330702246ProCureTwin Med, LLCLZA2026-06-01
10840330706756ProCureTwin Med, LLCLZA2026-06-01
10840330706763ProCureTwin Med, LLCLZA2026-06-01
10840330706770ProCureTwin Med, LLCLZA2026-06-01
10840330706787ProCureTwin Med, LLCLZA2026-06-01