FDA.reportPublic FDA data

MEDLINE

Primary DI
00197344153476
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
BCR911M
Catalog number
BCR911M
Device description
GLOVE,NITRILE,EXAM,ORG,M
Published
2025-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K200150000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200150000Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)Medline Industries, Inc.2020-10-26LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30197344153477PackageGS110In Commercial Distribution
00197344153476PrimaryGS10
10197344153473Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3019734415347730197344153477
00197344153476001973441534761973441534760197344153476
1019734415347310197344153473

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry, Protect from freezing - avoid excessive heat, Keep Away from Sunlight, Shield from fluorescent lighting, x-rays, moisture and ozone

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133836MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
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
00768627017282Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
10840330702208ProCureTwin Med, LLCLZA2026-06-01
10840330702215ProCureTwin Med, LLCLZA2026-06-01
10840330702222ProCureTwin Med, LLCLZA2026-06-01
10840330702239ProCureTwin Med, LLCLZA2026-06-01