AccessGUDID - DEVICE: Sempermed Syntegra UV Polyisoprene Surgical Glove (00841277105773)

GUDID

Device Identifier (DI) Information

Brand Name: Sempermed Syntegra UV Polyisoprene Surgical Glove
Version or Model: SUV800
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SUV800
Company Name: SEMPERMED USA, INC.

Primary DI Number: 00841277105773
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 40
Labeler D-U-N-S® Number*: 004072158 *Terms of Use

Device Description: Sempermed Syntegra UV Polyisoprene Surgical Glove, size 8.0

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56293	Polyisoprene surgical glove, non-powdered, non-antimicrobial	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OPA	Powder-Free Non-Natural Rubber Latex Surgeon'S Gloves
KGO	Surgeon'S Gloves

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191860	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3d513a69-5398-4059-9737-a6fd15c34831
Public Version Date: November 09, 2022
Public Version Number: 1
DI Record Publish Date: November 01, 2022