PrimaPro 3XL-PE-GOWN

GUDID 20850022371596

PrimaPro GentleWare Polyethylene Isolation Gown with Thumbholes 3XL, 15 Gowns/Box, 5 Box/Case, 75 Gowns/Case, Single Use

PRIMARY PRODUCTS COMPANY

Professional examination gown, single-use Professional examination gown, single-use Professional examination gown, single-use Professional examination gown, single-use Professional examination gown, single-use Professional examination gown, single-use Professional examination gown, single-use Professional examination gown, single-use

• Primary Device ID: 20850022371596
• NIH Device Record Key: 1bd650ba-56e3-43d0-8f1d-6589bd1e9c49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PrimaPro
• Version Model Number: 3XL-PE-GOWN
• Catalog Number: 3XL-PE-GOWN
• Company DUNS: 089569581
• Company Name: PRIMARY PRODUCTS COMPANY
• Device Count: 15
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850022371592 [Primary]
GS1	10850022371599 [Package]; Contains: 00850022371592; Package: CASE [5 Units]; In Commercial Distribution
GS1	20850022371596 [Unit of Use]

FDA Product Code

• FME: Gown, Examination

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-01
• Device Publish Date: 2021-08-24

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• 10850022371322: PrimaPro Gentle Guard Latex Powder Free Examination Glove Large, 100 Gloves/Box, 10 Box/Case, 1,
• 10850022371315: PrimaPro Gentle Guard Latex Powder Free Examination Glove Medium, 100 Gloves/Box, 10 Box/Case, 1
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• 10850022371179: PrimaPro Gentle Guard Soft Shield Nitrile Powder Free Examination Glove Medium, 100 Gloves/Box,
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• 10850022371087: PrimaPro Gentle Guard Comfort Fit Nitrile Powder Free Examination Glove Medium, 200 Gloves/Box,
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