Full Coverage Isolation Gown #RR-300FC

GUDID 20813360023046

ICP MEDICAL, LLC

Surgical/examination garment kit

• Primary Device ID: 20813360023046
• NIH Device Record Key: 796d0eed-c96f-48d6-999e-e8216e8fc6e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Full Coverage Isolation Gown #RR-300FC
• Version Model Number: 1
• Company DUNS: 078780963
• Company Name: ICP MEDICAL, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813360023042 [Primary]
GS1	10813360023049 [Package]; Contains: 00813360023042; Package: Bag [10 Units]; In Commercial Distribution
GS1	20813360023046 [Package]; Contains: 10813360023049; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160361

FDA Product Code

• FYC: Gown, Isolation, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-04

Devices Manufactured by ICP MEDICAL, LLC

• 10688162000518 - Protexter: 2025-08-20 Isolation gown, SMS, AAMI Level II, Yellow, Over the Head, Full Coverage, Thumb Loop with Elastic Wrist, 2XL
• 00688162000030 - Protexer: 2025-08-18 Scrub Bottom, SMS, Blue, Elastic Waist, Large
• 00688162290004 - Protexer: 2025-08-18 Scrub Top, SMS, Blue, V-Neck, Large
• 00688162390506 - Protexer: 2025-08-18 Scrub Top, SMS, Blue, V-Neck, XL
• 10813360021465 - Protexer: 2025-08-18 Lab Coat, Blue, Traditional Collar, Knit Cuffs, Snap Front, 3 pockets, Universal
• 00813360021772 - Protexer: 2025-08-18 Scrub Bottom, SMS, Blue, Elastic Waist, XL
• 00688162000597 - Protexter: 2025-07-18 Isolation gown, Yellow, AAMI Level 2, SMS, Neck Tie, Elastic Cuff, Universal
• 00068162000511 - Protexter: 2023-11-08 Isolation gown, SMS, AAMI Level II, Yellow, Over the Head, Full Coverage, Thumb Loop with Elastic Wrist, 2XL