Spunlace Reinforced Surgical Gown (Non-Sterile)-M

GUDID 14710415369304

The Spunlace Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The Spunlace Reinforced Gown is made from Spunlace material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) the chest area is reinforced with additional layer of SMS material. (b) the sleeve area is reinforced with additional layer of SMS material. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

MEDTECS (TAIWAN) CORP.

Surgical gown, single-use

• Primary Device ID: 14710415369304
• NIH Device Record Key: c781bca3-2512-4c3e-8af8-5cc8d73dfd99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spunlace Reinforced Surgical Gown (Non-Sterile)-M
• Version Model Number: JCSG84700M
• Company DUNS: 658023890
• Company Name: MEDTECS (TAIWAN) CORP.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04710415369307 [Primary]
GS1	14710415369304 [Package]; Contains: 04710415369307; Package: Carton [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102692

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

[14710415369304]

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[14710415369304]

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[14710415369304]

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[14710415369304]

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[14710415369304]

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[14710415369304]

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[14710415369304]

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[14710415369304]

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[14710415369304]

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Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-04
• Device Publish Date: 2020-11-26

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