Snow Lotus

Basic Information

• Brand Name: Snow Lotus
• Primary DI: 06936610210314
• Version / Model: 9.5
• Company Name: Beijing Reagent Latex Products Factory
• Labeler DUNS: 653865840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-17
• Public Version: 1
• Public Version Date: 2021-09-27
• Public Version Status: New
• Public Device Record Key: b53869ed-ef0a-4222-b90c-f4e8610a08c8

Device Description

Powdered Sterile Latex Surgical Gloves

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: Yes
• 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
Package	16936610210311	GS1	small box	50	In Commercial Distribution
Primary	06936610210314	GS1
Package	26936610210318	GS1	large box	8	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K062797	000