FDA.reportPublic FDA data

Bosma Enterprises

Primary DI
20818634020042
Brand
Bosma Enterprises
Company
Bosma Enterprises
Model
72-90602
Catalog number
72-90602
Device description
Vinyl Powder Free Exam Gloves Medium 100/Box
Published
2021-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070076000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070076000POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED)Jiangsu Cureguard Glove Co., Ltd.2007-02-22LYZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30818634020049PackageGS110In Commercial Distribution
20818634020042PrimaryGS10
00818634020048Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081863402004930818634020049
2081863402004220818634020042
00818634020048008186340200488186340200480818634020048

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-362-5463kimm@bosma.org

Regulatory Flags#

DUNS number
878070325
Device count
100
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818634025606C.R. Bard10-01011210-0101122026-05-14
10818634025613C.R. Bard10-01011410-0101142026-05-14
10818634025620C.R. Bard10-01011610-0101162026-05-14
10818634025637C.R. Bard10-01011810-0101182026-05-14
10818634025644C.R. Bard10-01012010-0101202026-05-14
10818634025651C.R. Bard10-12061010-1206102026-05-14
10818634025668C.R. Bard10-12061210-1206122026-05-14
10818634025675C.R. Bard10-12061410-1206142026-05-14
10818634025682C.R. Bard10-12061610-1206162026-05-14
10818634025699C.R. Bard10-12061810-1206182026-05-14
10818634025705C.R. Bard10-12062010-1206202026-05-14
00818634020635Bosma Enterprises10-8020PAO10-8020PAO2026-05-14
00818634025210Bosma Enterprises10-9030WIL10-9030WIL2026-05-14
00818634025838Bosma Enterprises10-9030WI210-9030WI22026-05-14
00818634026040Bosma Enterprises10-8020SAL210-8020SAL22026-05-14
10818634021387Gammex71-851171-85112021-07-01
10818634021394Gammex71-851271-85122021-07-01
10818634021400Gammex71-851371-85132021-07-01
10818634021417Gammex71-851471-85142021-07-01
10818634021424Gammex71-851571-85152021-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536905610BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905627BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905634BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905641BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905658BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00850084857218MedClickMedClick LLCLYZ2026-07-22
00850084857225MedClickMedClick LLCLYZ2026-07-22
00850084857232MedClickMedClick LLCLYZ2026-07-22
00850084857249MedClickMedClick LLCLYZ2026-07-22
00850084857256MedClickMedClick LLCLYZ2026-07-22
00850084857263MedClickMedClick LLCLYZ2026-07-22
00850084857270MedClickMedClick LLCLYZ2026-07-22
00850084857287MedClickMedClick LLCLYZ2026-07-22
00850084857294MedClickMedClick LLCLYZ2026-07-22
00850084857300MedClickMedClick LLCLYZ2026-07-22
00850084857317MedClickMedClick LLCLYZ2026-07-22
00850084857324MedClickMedClick LLCLYZ2026-07-22
00080196515939CURADMEDLINE INDUSTRIES, INC.LYZ2026-07-06
00810145952054NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952061NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952078NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952085NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952092NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00713733712835MeijerMEIJER, INC.LYZ2026-06-05
10840330701911ProCureTwin Med, LLCLYZ2026-05-27
10840330701928ProCureTwin Med, LLCLYZ2026-05-27
10840330701935ProCureTwin Med, LLCLYZ2026-05-27
10840330701942ProCureTwin Med, LLCLYZ2026-05-27
10840330701959ProCureTwin Med, LLCLYZ2026-05-27
10840330701966ProCureTwin Med, LLCLYZ2026-05-27