AccessGUDID - DEVICE: Snow Lotus (06936610210260)

GUDID

Device Identifier (DI) Information

Brand Name: Snow Lotus
Version or Model: 7
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Beijing Reagent Latex Products Factory

Primary DI Number: 06936610210260
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 653865840 *Terms of Use

Device Description: Powdered Sterile Latex Surgical Gloves

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGO	Surgeon'S Gloves

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062797	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: 00eb96fa-da2c-4392-bcf3-ebe95a0c75e2
Public Version Date: September 27, 2021
Public Version Number: 1
DI Record Publish Date: September 18, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
16936610210267	50	06936610210260		In Commercial Distribution	small box
26936610210264	8	16936610210267		In Commercial Distribution	large box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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