HK522

GUDID 26931918173839

Surgical Gown_Non-Reinforced_M_W/ two hand towel_Sterile_32EA/CS

GRI Medical & Electronic Technology Co., Ltd.

Surgical gown, single-use

• Primary Device ID: 26931918173839
• NIH Device Record Key: 85c14392-a0a9-440d-b2f0-9a030c0beb43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HK522
• Version Model Number: 90-8010-S2
• Company DUNS: 679894738
• Company Name: GRI Medical & Electronic Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	16931918173832 [Primary]
GS1	26931918173839 [Package]; Contains: 16931918173832; Package: [32 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102652

FDA Product Code

• FYA: Gown, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-28
• Device Publish Date: 2023-07-20

Devices Manufactured by GRI Medical & Electronic Technology Co., Ltd.

• 06931918160774 - Invenio: 2025-07-11 Poly incise drape_48"x51"_w/pouch_Non-Sterile_1000ea/cs
• 06931918112780 - Surgi Guard: 2025-06-30 Gown_Standard_Large_Non-Sterile_44ea/cs
• 26931918113439 - Alleset: 2025-06-30 Band Bag_Dome Style_sewn elastic_20in circular_Sterile_50ea/cs
• 06931918115095 - Alleset: 2025-06-30 Surgical Instrument Tray_Half Shallow_Non-sterile_2380ea/cs
• 26931918115334 - HALYARD: 2025-06-30 Valueselect*Gown_Film reinforced_XX-Large_W/ 2 hand towels_35g SMS_Sterile_22ea/cs
• 06931918118010 - Alleset: 2025-06-30 EENT Split Drape_315cmx193cm_Non-sterile_240ea/cs
• 06931918118478 - Invenio: 2025-06-30 Drape_GYN/Urology_285cmx337.5cm_Non-Sterile_16ea/cs
• 06931918119581 - Alleset: 2025-06-30 OR Towel_Blue_17inx24in_Non-sterile_400ea/cs