FDA.reportPublic FDA data

Gammex

Primary DI
20818634021544
Brand
Gammex
Company
Bosma Enterprises
Model
71-AN85755
Catalog number
71-AN85755
Device description
Gammex Non-Latex PI Surgical 5.5 - 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20818634021544PackageGS14In Commercial Distribution
10818634021547PrimaryGS10
00818634021540Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081863402154420818634021544
1081863402154710818634021547
00818634021540008186340215408186340215400818634021540

GMDN Terms#

Term, Definition table
TermDefinition
Polyisoprene surgical glove, non-powdered, non-antimicrobialA device made of polyisoprene 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. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, 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
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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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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Primary DI, Brand, Company table
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07323190091379Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
07323190091454Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-03-02
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