CUSTOMED

Basic Information

• Brand Name: CUSTOMED
• Primary DI: M20890030517
• Version / Model: 712057693051
• Catalog Number: 9003051
• Company Name: CUSTOMED INC
• Labeler DUNS: 627572217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4f2130e4-6bc4-42c7-9136-051efe4aa27c

Device Description

CUSTOMFEEL LATEX POWDERED SURGICAL GLOVE 8

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGO	Surgeon'S Gloves	General, Plastic Surgery	878.4460	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47179	Hevea-latex surgical glove, powdered	A sterile 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 covered with talcum powder primarily to facilitate donning and removal; it does not have antimicrobial features. 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M20890030517	HIBCC
Unit of Use	M20890030510	HIBCC
Package	M20890030511	HIBCC	50PR/BOX	50	In Commercial Distribution
Package	M20890030512	HIBCC	50PR/BOX, 5BOX/CS	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K010198	000

Device Sizes

Type	Value	Unit	Text
Circumference	8.0	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid Ozone.
• Type: Special Storage Condition, Specify
• Special Conditions: Store in Cool Dry Place.