FDA.report

Encore

Primary DI
20818634021100
Brand
Encore
Company
Bosma Enterprises
Model
71-5785003
Catalog number
71-5785003
Device description
Encore Latex Textured Surgical 7.0 - 50 Pair/Box
Published
2021-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KGOSurgeon'S Gloves

Product Code Classifications

CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20818634021100PackageGS14In Commercial Distribution
10818634021103PrimaryGS10
00818634021106Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2081863402110020818634021100
1081863402110310818634021103
00818634021106008186340211068186340211060818634021106

GMDN Terms

TermDefinition
Hevea-latex surgical glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; 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 both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

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

Contacts

PhoneEmail
800-362-5463kimm@bosma.org

Regulatory Flags

DUNS number
878070325
Device count
50
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10818634025408Bosma Enterprises72-5080172-508012025-08-25
10818634025415Bosma Enterprises72-5080272-508022025-08-25
10818634025422Bosma Enterprises72-5080372-508032025-08-25
10818634025439Bosma Enterprises72-5080472-508042025-08-25
10818634025484Bosma Enterprises72-5080072-508002025-08-25
10818634025491Bosma Enterprises72-5080572-508052025-08-25
00818634025364Good Works72-5040172-504012025-03-14
10818634025378Good Works72-5040272-504022025-03-14
10818634025385Good Works72-5040372-504032025-03-14
10818634025392Good Works72-5040472-504042025-03-14
10818634025446Bosma Enterprises72-5090172-509012025-03-14
10818634025453Bosma Enterprises72-5090272-509022025-03-14
10818634025460Bosma Enterprises72-5090372-509032025-03-14
00818634025470Bosma Enterprises72-5090472-509042025-03-14
10818634025507Bosma Enterprises72-5090572-509052025-03-14
10818634025514Bosma Enterprises72-50900 72-50900 2025-03-14
00818634025524Bosma Enterprises10-8020GA10-8020GA2024-03-15
10818634025538Bosma Enterprises10-8020GAW10-8020GAW2024-03-15
10818634025545Good Works72-5060472-506042024-03-15
10818634025552Good Works72-5060372-506032024-03-15

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